Efficacy and Safety of Topical Sucralfate for Post-Tonsillectomy Pain in Children: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Abstract

Importance:

Post-tonsillectomy pain remains difficult to manage in children despite standard analgesia. Topical sucralfate may reduce pain by coating the tonsillar bed and promoting mucosal recovery.

Objective:

To evaluate the efficacy and safety of topical sucralfate in reducing post-tonsillectomy pain and accelerating recovery in children.

Design:

Systematic review and meta-analysis of randomized controlled trials.

Setting:

PubMed, Web of Science, Cochrane Library, and Google Scholar were searched until July 2025.

Participants:

Children aged ≤18 undergoing tonsillectomy.

Interventions:

Topical sucralfate applied to the tonsillar bed intraoperatively or given postoperatively as an oral rinse.

Main Outcomes and Measures:

The overall effect size for the primary outcome (postoperative pain during the first postoperative week) was presented as standardized mean differences (SMDs), while secondary outcomes (analgesic use, return to oral intake, and adverse events) were reported as descriptive comparisons across trials.

Results:

Six randomized trials involving 485 children aged 3 to 12 years were included. Topical sucralfate reduced postoperative pain, with the greatest benefit observed from postoperative day 2 onward compared with placebo. On postoperative day 1, sucralfate lowered pain scores (5 trials; n = 432; SMD, −1.01; 95% confidence interval, −1.45 to −0.57; P < .00001). Sucralfate reduced systemic analgesic use and supported an earlier return to oral intake. Adverse events, including bleeding, nausea, and vomiting, occurred at similar rates in both groups.

Conclusions:

Topical sucralfate is a safe and effective adjunct after pediatric tonsillectomy. It reduces early postoperative pain and improves functional recovery.

Relevance:

These findings support topical sucralfate as a simple, low-cost option for postoperative analgesia in children. Larger trials are needed to confirm these benefits.

Graphical Abstract

Keywords

tonsillectomy postoperative pain sucralfate children randomized controlled trials

Key Messages

Topical sucralfate reduces early postoperative pain after pediatric tonsillectomy, with the greatest benefit observed during the first 3 postoperative days.

Sucralfate use is associated with reduced analgesic requirements and earlier return to oral intake, supporting improved postoperative recovery.

Topical sucralfate appears safe and well tolerated, with no increase in postoperative bleeding or other adverse events compared with placebo.

Introduction

Tonsillectomy is one of the most commonly performed surgical procedures in children worldwide, primarily indicated for recurrent throat infections and sleep-disordered breathing. Despite its clinical effectiveness, postoperative recovery is frequently painful, making post-tonsillectomy pain a major challenge in pediatric perioperative care.¹

Postoperative pain after tonsillectomy can significantly impair oral intake, sleep quality, and overall well-being.¹ In a prospective cohort of 121 children, nearly one-quarter continued to report clinically significant pain on postoperative day 10, and other studies similarly demonstrate substantial pain during the first postoperative week despite standard analgesic strategies.^2-5

Analgesic management typically relies on paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs). However, pain control remains inconsistent, and concerns regarding postoperative bleeding continue to limit NSAID use in some settings. Opioids have declined in routine pediatric practice because of limited additional benefit and important safety risks, including respiratory depression, nausea, and vomiting. Inadequate pain control remains common, highlighting the need for safer and more effective adjunctive therapies.^6,7

Sucralfate is a mucoprotective agent. It adheres to damaged mucosa, creating a protective barrier that promotes epithelial repair. After tonsillectomy, sucralfate can form the same local barrier over the tonsillar wound, which can lessen mechanical irritation and reduce postoperative pain during healing.^8,9

Several randomized trials have evaluated the use of topical sucralfate after pediatric tonsillectomy. Harshvardhan et al reported reductions in throat pain, otalgia, and trismus beginning on postoperative day 2, while Bista et al demonstrated earlier return to oral intake without an increase in postoperative complications.^8,10 The current systematic review and meta-analysis aim to address these gaps by synthesizing randomized controlled trial (RCT) evidence on the efficacy and safety of topical sucralfate for post-tonsillectomy pain reduction and postoperative functional recovery in children.

Materials and Methods

Literature Search Strategy

PubMed, the Cochrane Library, Web of Science, and Google Scholar were searched from inception through July 3, 2025 to identify eligible randomized trials. The review was registered in PROSPERO (CRD420251083326),¹¹ and followed PRISMA guidelines.¹² The search was not restricted by publication date. The following Boolean expressions were applied: (tonsillectomy OR tonsil surgery OR adenotonsillectomy OR tonsil removal) AND (sucralfate OR topical sucralfate OR mucosal protectant) AND (pain OR postoperative pain OR analgesia OR discomfort OR sore throat OR pain score OR visual analogue scale OR FLACC) AND (child OR paediatric OR children OR adolescent OR youth OR school-age) AND (placebo OR saline OR clindamycin).

Inclusion and Exclusion Criteria

Studies were included if they met the following PICO criteria: Patients (P): children and adolescents aged 18 years or younger undergoing tonsillectomy, with or without adenoidectomy; Intervention (I): topical sucralfate; Comparator (C): placebo, saline, standard care, or other topical agents; Outcomes (O): postoperative pain, analgesic use, oral intake, wound healing, hemorrhage, and adverse events. Only RCTs published in English were included. Non-randomized studies, adult-only populations, mixed-age cohorts without separate pediatric data, and non-original publications were excluded. Studies were eligible if they reported at least 1 relevant postoperative outcome at any postoperative time point.

Selection of Articles and Data Extraction

Records were imported into Mendeley for duplicate removal and then screened in Rayyan. Four reviewers independently assessed titles, abstracts, and full- text articles, with disagreements resolved through discussion and consensus. Extracted data included study characteristics, participant demographics, surgical technique, intervention regimen, pain scales, assessment time points, and group outcome data. Secondary outcomes included analgesic consumption, recovery measures, and adverse events. The study selection process is summarized in Figure 1 in accordance with PRISMA guidelines.

Figure 1.

PRISMA flowchart.

Quality Assessment

The Cochrane risk-of-bias tool for randomized trials (RoB2)¹³ was used to assess the risk of bias in the included studies. Each domain was rated as low risk, some concerns, or high risk of bias, and an overall risk of bias judgment was assigned to each study. Two authors independently performed the assessment, and disagreements were resolved through discussion with a third author. Inter-rater agreement was 92% (κ = 0.84). No studies were rated as high risk of bias; therefore, none were excluded on this basis. Domain-level assessments for each study are provided in Supplementary Table S2.

Certainty Assessment

The certainty of evidence for each major outcome (postoperative pain on days 1-7) was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework.¹⁴ Evidence from RCTs was initially rated as high certainty and downgraded based on 5 domains: risk of bias, inconsistency, indirectness, imprecision, and publication bias. Summary of Findings tables were constructed, and certainty ratings (high, moderate, low, or very low) were assigned with justification for all downgrade decisions.

Statistical Analysis

Meta-analysis was performed using RevMan version 5.4.1 (The Cochrane Collaboration, Copenhagen, Denmark).¹⁵ The primary outcome was postoperative pain measured on validated scales (Faces Pain Scale – Revised, Oucher, or visual analog scale (VAS). Based on the available reporting across trials, we prespecified the following postoperative time points for meta‑analysis: days 1, 2, 3, 4, 5, and 7. Secondary outcomes were analgesic consumption, return to oral intake, and adverse events (including hemorrhage, nausea, vomiting, fever, halitosis, and otalgia).

Continuous outcomes were summarized as standardized mean differences (SMDs) with 95% confidence intervals (CIs). Negative SMDs indicate lower pain scores in the sucralfate group compared with placebo. A random-effects model was applied to account for between-study variability. For studies reporting medians and interquartile ranges (IQRs), means and standard deviations (SDs) were estimated using the method described by Wan et al.¹⁶ Two authors independently recalculated all SMDs using extracted means and SDs from each trial, and discrepancies were resolved by consensus.

Statistical heterogeneity was assessed using the I² and χ² statistics. An I² value ≥50% was considered substantial heterogeneity. For outcomes with high heterogeneity, we performed a leave-one-out sensitivity analysis. Publication bias was not formally assessed because fewer than 10 studies were available per meta‑analysis, which makes statistical tests for funnel plot asymmetry unreliable. Accordingly, we did not perform funnel plots or Egger’s regression.

Results

Study Characteristics

Table 1 summarizes 6 RCTs conducted between 2007 and 2018 at tertiary pediatric otolaryngology centers in Brazil, Turkey, India, and Iran. The trials included 485 children aged 3 to 12 years. All studies compared topical sucralfate, administered as intraoperative irrigation or as a postoperative swish-and-swallow regimen (1-3 g in 50-120 mL of solution, given 3-4 times daily for 3-7 days), with placebo or standard care after tonsillectomy. Tonsillectomy techniques varied across the included studies. Five trials used cold dissection with a snare; hemostasis was achieved by pressure and ligatures,¹⁰ wet gauze compression and suture,^17-19 or by standard suture ligation.²⁰ One trial used thermal welding.²¹ In the cold‑dissection studies, no electrocautery was applied to the tonsillar bed.

Table 1.

Study Characteristics of Randomized Trials Evaluating Topical Sucralfate for Post-Tonsillectomy Pain in Children.

First author (y)	Setting (country)	Sample size (n)	Sex (boys/girls)	Age, mean ± SD (range), y	Follow-up	Technique	Intervention (dose and regimen)
Bista et al (2018)¹⁰	Tertiary ENT Center, Puducherry, India	56 (28 sucralfate, 28 placebo)	24/32	Sucralfate: 10.36 ± 2.39; Control: 10.89 ± 3.22	7 d	Cold dissection and snare	Sucralfate 1 g sucralfate in 50 mL, swish- and-swallow QID × 7 d; placebo: glucose solution
Gautham et al (2014)²⁰	ENT Department, Karnataka, India	120 (4 groups; n = 30 each)	65/55	Group A: 8.50 ± 4.05; Group B: 7.9 ± 3.95; Group C: 8.1 ± 4.2; Group D: 8.25 ± 3.8 (5-12 y)	7 d	Dissection and snare	Sucralfate (Group C): rinse 10 mL QID × 7 d; comparator group: ropivacaine, bupivacaine, saline
Jahanshahi et al (2014)¹⁷	Besat Hospital, Iran	101 analyzed (34 sucralfate, 33 clindamycin, 34 placebo)	44/57	8.0 ± 1.77 (range 6-12)	5 d	Cold dissection	Sucralfate 3 g/120 mL saline; rinse 10 mL TID × 3 d; placebo: lactose solution
Taşkın et al (2013)²¹	Two teaching hospitals, Turkey	170 (85 sucralfate, 85 placebo)	86/84	Sucralfate: 7.25 ± 1.90; placebo: 8.44 ± 2.41 (range 3-12)	7 d	Thermal welding	Sucralfate group 1 g/ 60 mL, applied intraoperatively + rinses 10 mL QID × 7 d; placebo: lactose solution
Miura et al (2009)¹⁸	Tertiary Pediatric ENT Ward, Brazil	80 analyzed (41 sucralfate, 41 placebo)	41/41	Sucralfate: 6.37 (SD NR); placebo: 7.05 (range 4-12)	5 d	Cold dissection	Sucralfate group: 1 g/60 mL irrigation intraoperatively + rinses 10 mL QID × 5 d; placebo: lactose solution
Sampaio et al (2007)¹⁹	University Hospital of Brasília, Brazil	58 analyzed (29 sucralfate, 29 placebo)	NR	Sucralfate: 5.8 ± 2.8; placebo: 6.5 ± 1.9 (range 3-12)	7 d	Cold dissection	Sucralfate 1 g/60 mL irrigation intraoperatively + rinses 10 mL QID × 7 d; placebo: lactose solution

Abbreviations: ENT, ear-nose-throat; NR, not reported; QID, 4 times daily; SD, standard deviation; TID, 3 times daily.

Pain was measured over 5 to 7 postoperative days using validated pediatric scales, including the Faces Pain Scale – Revised. Secondary outcomes included analgesic use, return to oral intake, otalgia, trismus, and postoperative bleeding. Across trials, sucralfate was associated with lower pain scores from postoperative day 2 onward and earlier return to diet, without an increased risk of hemorrhage.

Risk of Bias Assessment

Figure 2 summarizes the risk-of-bias assessment for the 6 included RCTs. All pediatric tonsillectomy trials used appropriate randomization methods and achieved complete follow-up. However, each study showed at least 1 domain rated as “some concerns,” resulting in an overall judgment of “some concerns” across all 6 trials.

Figure 2.

ROB quality assessment of 6 RCT studies. RCT, randomized controlled trial.

The most frequent limitations involved deviations from intended interventions, incomplete blinding descriptions, missing outcome data with per-protocol analyses, and concerns regarding selective reporting due to the absence of prepublished protocols.^19-21

Jahanshahi et al, Taşkın et al, and Miura et al showed low risk across most domains, supported by clearer allocation concealment and well-described placebo matching.^17,18,21 Nonetheless, each retained an overall rating of “some concerns,” mainly because of missing outcome data exclusions or uncertainty in selective reporting.

To examine whether studies with “some concerns” influence the pooled effect estimates, we conducted sensitivity analyses restricted to the 3 trials that showed low risk across most RoB2 domains.^17,18,21

For day 1 pain, the pooled SMD from these trials^17,18,21 (n = 240) was −0.79 (95% CI −1.30 to −0.29; P = .002; I² = 74%), compared with −1.01 (95% CI −1.45 to −0.57) in the full analysis. The effect remained statistically significant, although the magnitude decreased slightly, indicating that inclusion of trials with some concerns did not substantially inflate the treatment effect.

For day 2 pain, the same 3 trials^17,18,21 (n = 240) produced a pooled SMD of −0.88 (95% CI −1.40 to −0.36; P = .001; I² = 78%), which closely matched the full estimate (−0.95). We could not perform similar sensitivity analyses for days 3 to 7 because fewer than 3 trials contributed data to these outcomes.

Primary Outcome: Postoperative Pain

Postoperative Day 1

In 5 trials (215 sucralfate and 217 placebo), topical sucralfate reduced pain on postoperative day 1 (SMD −1.01, 95% CI −1.45 to −0.57; P < .00001), although heterogeneity was substantial (P = .002; I² = 77%; Figure 3). Excluding Sampaio et al in a leave-one-out analysis produced a similar effect estimate (SMD −1.27, 95% CI −1.53 to −1.01; Z = 9.18, P < .00001) and lower heterogeneity (I² = 22%; Figure S1), indicating that this study did not drive the overall result. Sampaio et al differed from other trials because investigators administered sucralfate intraoperatively only, without postoperative dosing, and assessed pain at 24 hours, capturing a transient rather than sustained benefit; they observed pain reduction at 6 hours but no difference at 24 hours. Taşkın et al also contributed to variability, as it was the only trial using thermal welding and reported a smaller treatment effect (SMD −0.34 vs −0.99 to −2.11 in cold dissection trials).

Figure 3.

Forest plot of standardized mean differences in postoperative pain (day 1) comparing topical sucralfate versus placebo.

Postoperative Day 2

In 4 randomized trials including 186 patients receiving sucralfate and 188 receiving placebo, topical sucralfate reduced pain on postoperative day 2 (pooled SMD −0.95, 95% CI: −1.36 to −0.54; Z = 4.53, P < .00001), although heterogeneity was substantial (I² = 70%; Figure 4). Excluding Bista et al yielded a similar effect estimate across 3 trials (n = 158 sucralfate vs 160 placebo; SMD −1.14, 95% CI −1.43 to −0.85, P < .00001) and lowered heterogeneity (I² = 30%; Figure S2), confirming that the analgesic benefit on day 2 remained robust. Clinical and methodological differences likely explained the between-trial variability. Bista et al converted median (IQR) data to mean (SD) and enrolled older children (mean 10.4 vs 6-8 years), which may have introduced imprecision. Jahanshahi et al administered sucralfate for only 3 days rather than 5 to 7 days and reported a smaller effect (SMD −0.66 vs −0.94 to −1.74), suggesting that treatment duration may influence outcomes. Miura et al reported markedly lower absolute pain scores in both groups (sucralfate: 2.1; placebo: 4.2) than other trials, possibly due to differences in co-intervention or pain scale application.

Figure 4.

Forest plot of standardized mean differences in postoperative day 2 pain comparing topical sucralfate versus placebo.

Postoperative Day 3

A meta-analysis of 4 randomized trials including 186 children treated with topical sucralfate and 188 patients receiving placebo showed a significant reduction in pain on postoperative day 3 (SMD −1.07, 95% CI −1.29 to −0.85; P < .00001). The studies showed negligible heterogeneity (I² = 0%), supporting a consistent benefit across the trials (Figure 5A).

Figure 5.

Forest plot of standardized mean differences in postoperative pain comparing topical sucralfate versus placebo. (A) Day 3. (B) Day 4.

Postoperative Day 4

A meta-analysis of 3 randomized trials including 158 children receiving topical sucralfate and 160 receiving placebo showed a moderate reduction in pain on postoperative day 4 (SMD −0.66, 95% CI −1.11 to −0.21; Z = 2.86, P = .004), with substantial heterogeneity (I² = 72%; Figure 5B). Difference in treatment duration and surgical technique likely explained this variability. Jahanshahi et al administered sucralfate for only 3 days, so day 4 reflected treatment discontinuation and a waning effect (SMD −1.17). Taşkın et al, the only trial using thermal welding, reported the smallest benefit (SMD −0.28). Miura et al reported consistently lower absolute pain scores in both groups. The small number of trials prevented formal subgroup analysis.

Postoperative Day 5

A meta-analysis of 3 randomized trials including 158 children treated with topical sucralfate and 160 receiving placebo found a small, non-significant reduction in pain on postoperative day 5 (SMD −0.27, 95% CI −0.64 to 0.10; P = .15), with moderate heterogeneity (I² = 60%; Figure 6A). Taşkın et al contributed most to this variability, reporting a null effect (SMD 0.01), whereas Jahanshahi et al and Miura et al reported small-to-moderate reductions favoring sucralfate. By day 5, postoperative pain naturally declines in both groups, and between-group differences become clinically minimal.

Figure 6.

Forest plot of standardized mean differences in postoperative pain comparing topical sucralfate versus placebo. (A) Day 5. (B) Day 7.

Postoperative Day 7

A meta-analysis of 3 randomized trials including 142 children treated with topical sucralfate and 142 receiving placebo found no significant reduction in pain on postoperative day 7 (SMD −0.64, 95% CI −1.86 to 0.57; Z = 1.04, P = .30), with extreme heterogeneity (I² = 95%; Figure 6B). This variability likely reflects a statistical artefact rather than true inconsistency in treatment effect. Bista et al reported an unusually high placebo pain score at day 7 (3.33/10), which differed from other trials. In contrast, Miura et al (1.95) and Taşkın et al (0.35) showed that most children were pain-free by day 7 regardless of treatment.

Clinical Interpretation

To enhance interpretability, we converted pooled SMDs into approximate mean differences on a 0 to 10 pain scale (Faces Pain Scale – Revised or equivalent), using the pooled control-group SD (2.0-2.5). Sucralfate reduced pain by ~2.0 to 2.6 points on postoperative days 1 to 3, exceeding the minimum clinically significant difference (MCSD) of 2 points for the Faces Pain Scale – Revised in children with acute pain²² by day 4, the reduction remained clinically meaningful (~ 1.3-1.7 points). By day 5, the effect declined to ~0.5 to 0.8 points, falling below the MCSD and lacking statistical significance. Day 7 estimates were too unstable for reliable interpretation.

Adverse Events

Hemorrhage

Secondary bleeding occurred rarely across the 6 trials, and none of the studies reported major hemorrhage requiring surgical intervention. Jahanshahi et al reported 3 cases of bleeding on postoperative day 1 in the placebo group (9%) and none in the sucralfate group (P = .048).¹⁷ Miura et al detected blood-streaked saliva in both groups without a significant difference (sucralfate: 9/39 [23%] on day 1-1/39 [2.6%] on day 5; placebo: 12/41 [29%] on day 1-4/41 [9.8%] on day 5).¹⁸ Sampaio et al documented minor bleeding at 6, 24 hours, and day 7 in both arms, with no statistically significant differences; the investigators excluded 2 severe hemorrhage cases before analysis.¹⁹

Other Adverse Events

Three trials reported nausea and vomiting, with low and similar rates in the sucralfate and placebo groups; none showed a statistically significant difference.^17-19 Miura et al reported one exclusion in the sucralfate group due to high fever; otherwise, febrile events were rare and balanced between groups.¹⁸ Jahanshahi et al assessed halitosis and found a lower frequency in the clindamycin group, with no significant difference between sucralfate and placebo.¹⁷ Sampaio et al and Jahanshahi et al reported otalgia without significant between-group differences.^17,19 Bista et al evaluated trismus and observed fewer cases in the sucralfate group from postoperative day 2 onward; however, trismus reflects functional recovery rather than an adverse event.¹⁰ Jahanshahi et al also reported less food intolerance on day 1 in the sucralfate group (2/34 [6%] vs 9/34 [26%] placebo; P = .02; Table 2).¹⁷

Table 2.

Summary of Clinical Effects and Safety Outcomes of Topical Sucralfate After Pediatric Tonsillectomy.

First author (y)	Clinical effects (pain, analgesia, recovery)	Adverse events reported	Event rate (sucralfate vs placebo)
Bista et al (2018)¹⁰	Lower pain scores from POD2 onward; faster return to normal diet	No increase in bleeding; fewer otalgia/trismus cases	Bleeding: 0/28 vs 0/28
Gautham et al (2014)²⁰	Reduced pain compared with control; earlier food tolerance	No sucralfate-related complications	Complications: 0/30 vs 0/30
Jahanshahi et al (2014)¹⁷	Lower pain scores POD1-5; reduced acetaminophen use; less food intolerance on POD1	Minor bleeding more frequent in placebo group	POD1 bleeding: 0/34 vs 3/34 (9%)
Taşkın et al (2013)²¹	Lower mean pain across POD1-7; delayed first analgesic dose; fewer doses POD1-3	Rare nausea/vomiting; no intolerance	Complications: NR (balanced)
Miura et al (2009)¹⁸	Markedly lower pain scores POD1-5; fewer analgesic days	One exclusion due to fever; otherwise, no treatment-related events	Fever exclusion: 1/39 vs 0/41
Sampaio et al (2007)¹⁹	Pain reduction only at 6 h; no sustained benefit at 24 h or d 7	Minor bleeding similar; no significant adverse differences	Bleeding: NR (no difference)

Abbreviations: NR, not reported; POD, postoperative day.

GRADE Certainty Assessment

We assessed the certainty of evidence for each major outcome using the GRADE framework (Supplementary Table S1). We rated the evidence for pain reduction on postoperative day 3 and for hemorrhage risk as moderate certainty.

We rated the certainty of the evidence for pain on postoperative days 1, 2, and 4 as low, primarily because of substantial statistical heterogeneity; however, clinical differences in dosing regimens and surgical techniques largely explained this variability.

We rated the evidence for pain on postoperative days 5 and 7 as very low because of imprecision, CIs crossing the null, and, on day 7, extreme unexplained heterogeneity that likely reflects natural pain resolution rather than treatment failure. We also rated the evidence for return to a normal diet as low certainty, since studies used inconsistent outcome definitions and provided insufficient data for pooling. Because fewer than 10 studies were available for each meta‑analysis, publication bias could not be reliably assessed.

Discussion

Tonsillectomy is among the most commonly performed surgical procedures. Postoperative pain poses a persistent clinical challenge and limits oral intake, analgesic use, and overall recovery.^23-25 In this systematic review and meta-analysis, we synthesized evidence from pediatric randomized trials to evaluate topical sucralfate after tonsillectomy.

Our data show that topical sucralfate reduces postoperative pain compared with placebo or standard care. Patients who received sucralfate reported lower pain scores from postoperative days 1 through 7, with the greatest reduction observed between days 2 and 3. Sucralfate also reduced analgesic requirements, delayed rescue medication use, facilitated earlier return to a normal diet, and maintained a favorable safety profile without increasing postoperative bleeding or adverse events.

Bista et al,¹⁰ Gautham et al,²⁰ and Taskin et al²¹ reported that sucralfate reduced pain compared with placebo from days 1 to 7. Jahanshahi et al¹⁷ and Miura et al¹⁸ reported similar benefits over 5 days. Gautham et al,²⁰ who compared 4 arms including sucralfate, local anesthetics, and control, demonstrated that sucralfate provided pain relief comparable to ropivacaine, whereas bupivacaine lost efficacy after 4 hours. These findings align with other reports^26,27 and with 2 adult studies.^1,8

In contrast, Sampaio et al¹⁹ reported that sucralfate provided pain relief only during the first 6 postoperative hours, possibly because the investigators used dipyrone rather than paracetamol as a co-analgesic. The meta-analysis showed that sucralfate reduced discomfort on postoperative day 1 compared with the control group (SMD 0.1; 95% CI 1.45 to 0.57), and this effect persisted after excluding Sampaio et al. Significant pain reductions occurred on days 2 and 3, with attenuation by days 5 to 7.

In addition to reducing pain, sucralfate demonstrated an analgesic-sparing eﬀect. Four trials (Jahanshahi et al,¹⁷ Miura et al,¹⁸ Gautham et al,²⁰ and Taşkın et al,²¹) reported that sucralfate reduced paracetamol consumption, delayed the first dose, and shortened the duration of use, reflecting decreased reliance on standard analgesics. Studies of sucralfate after uvulopalatopharyngoplasty reported similar analgesic benefits.²⁸ Functional recovery also favored sucralfate, with most studies showing earlier return to a normal diet. Bista et al¹⁰ reported resumption of oral intake 1 day earlier in the sucralfate group, with similar findings in Jahanshahi et al,¹⁷ Miura et al.¹⁸ Gautham et al,²⁰ and Taşkın et al.²¹ The sucralfate group also showed lower rates of otalgia and trismus, supporting broader improvements in postoperative comfort and function. These findings align with Harshvardhan et al,⁸ who reported similar benefits in 64 patients across age groups.

Safety remains critical in pediatric care. All trials reported good tolerability of topical sucralfate and found no increase in postoperative bleeding compared with the control. Jahanshahi et al¹⁷ reported lower bleeding rates on postoperative day 1 in the sucralfate group. Adverse events – including nausea, vomiting, halitosis, and fever – were infrequent and occurred. Suparakchinda and Rawangban reported similar tolerability in 30 patients undergoing oral surgery.²⁹

The present meta‑analysis predominantly includes studies that used cold dissection with suture or gauze hemostasis, techniques that are less common today in settings where energy‑based modalities (eg, bipolar cautery, coblator, thermal welding) are preferred. Postoperative pain profiles differ by surgical technique; therefore, the magnitude of benefit observed in this review may not directly translate to procedures where electrocautery or intracapsular tonsillectomy is performed. Future trials should evaluate topical sucralfate in contemporary surgical contexts, and when possible, stratify results by hemostasis method.

Strength and Limitations

This systematic review provides the first meta-analytic evaluation of topical sucralfate for post-tonsillectomy pain in children. We included only prospective RCTs, which strengthened internal validity and minimized selection bias.

However, important limitations warrant consideration. The analysis revealed heterogeneity, likely driven by differences in surgical methods, sucralfate dose, frequency, timing, and pain assessment tools. Short follow-up periods (5-7 days) limited the evaluation of longer-term recovery and delayed the detection of complications. Five of 6 studies used cold dissection tonsillectomy, a technique less commonly used in centers where energy-based modalities predominate. Consequently, these findings may not fully reflect current practice, as postoperative pain profiles vary across surgical techniques. The predominance of positive findings also raises concerns for publication bias.

Clinical Implications

Our results suggest that topical sucralfate is a safe and effective adjunct for post-tonsillectomy pain in children, particularly early after surgery when pain limits oral intake.

It may reduce systemic analgesic exposure, given its association with lower paracetamol use and delayed first dosing.

Future multicenter trials should standardize the intervention (1 g in 50-60 mL water, 3-4 times daily for 5-7 days), background analgesia, use of a validated pain scale, reporting analgesic use in mg/kg/day, bleeding definitions, and include 10 to 14 days of follow-up is to detect late post-tonsillectomy complications.

Conclusion

This systematic review and meta-analysis shows that topical sucralfate reduces post-tonsillectomy pain during the early recovery period, particularly within the first 3 postoperative days, without increasing adverse events. Sucralfate also reduced analgesic use and facilitated earlier oral intake. Its low cost and ease of administration support its use as an adjunct to standard postoperative care. Larger multicenter studies with longer follow-up are needed to confirm these findings across diverse clinical settings.

Supplemental Material

sj-docx-1-ohn-10.1177_19160216261453906 – Supplemental material for Efficacy and Safety of Topical Sucralfate for Post-Tonsillectomy Pain in Children: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Supplemental material, sj-docx-1-ohn-10.1177_19160216261453906 for Efficacy and Safety of Topical Sucralfate for Post-Tonsillectomy Pain in Children: A Systematic Review and Meta-Analysis of Randomized Controlled Trials by Rasil H. Almughamisi, Ahmad Alkurdi, Shahad A. Aljohani, Amal M. Sunyur, Ruba M. Aljohani, Salwa A. Abualnassr, Aryam R. Aljabri, Aseel O. Alsubhi and Bushra N. Alrehaili in Journal of Otolaryngology - Head & Neck Surgery

Footnotes

ORCID iDs

Rasil H. Almughamisi

Aseel O. Alsubhi

Ethical Considerations

This review was conducted according to the PRISMA guidelines. As it is based on previously published data, ethical approval and patient consent were not applicable. The protocol was registered with PROSPERO ID: CRD420251083326.

Author Contributions

All authors have reviewed the final version to be published and agreed to be accountable for all aspects of the work. Concept and design: Rasil H. Almughamisi, Shahad A. Aljohani, Amal M. Sunyur, Aryam R. Aljabri, Aseel O. Alsubhi, Ruba M. Aljohani, and Ahmad Alkurdi. Acquisition, analysis, or interpretation of data: Rasil H. Almughamisi, Bushra N. Alrehaili, and Salwa A. Abualnassr. Drafting of the manuscript: Rasil H. Almughamisi, Shahad A. Aljohani, Amal M. Sunyur, Salwa A. Abualnassr, Aseel O. Alsubhi, Ruba M. Aljohani, and Aryam R. Aljabri. Critical review of the manuscript for important intellectual content: Rasil H. Almughamisi, Aryam R. Aljabri, Bushra N. Alrehaili, and Ahmad Alkurdi. Supervision: Rasil H. Almughamisi and Ahmad Alkurdi.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Data Availability Statement

Upon reasonable request, the corresponding author will provide data to support the findings of the study.

Supplemental Material

Additional supporting information is available in the online version of the article.

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