Pack or No Pack after Ear Surgery: A Randomized Controlled Trial

Abstract

Objective: 1) To see if there is a difference in patient and clinician reported outcomes between patients randomized to postoperative ear packing, compared to those who did not have the ear packed after middle ear surgery. 2) To see if there is a also a difference in hearing outcome between both groups.

Method: Randomized controlled trial of adult patients to have either Bismuth Iodoform Paraffin Paste pack or no ear pack postoperatively after primary canal wall up middle ear surgery. Setting: tertiary teaching hospital, UK (2011). Outcome measures: clinicians/patients recorded visual analogue scale scores at 3 weeks and 3 months postoperatively. Audiometry was recorded at 3 months.

Results: Thirty-two patients of similar sex and age were randomized to the 2 treatment arms. There was no statistically significant inter-group difference in 3-week composite clinician and patients mean visual analogue scores (146 mm versus 184 mm [P = .3]). The graft take rates and the appearance of the ear canals at 3 months were similar in both groups (P = 1.0 for both outcomes). There was also no significant inter-group difference in the change in mean air conduction thresholds in response to surgery (11.3 dB and 3.5 dB) in the ear pack and no pack groups, respectively (P = .08).

Conclusion: No differences in total patient symptoms and clinician findings or hearing were demonstrated between patients with a postoperative pack compared to those without a postoperative pack following middle ear surgery. This pilot study provides justification for a larger clinical trial to investigate the need for postoperative ear canal packing.