Abstract
Background:
In Norway newly diagnosed children suffering from Acute Lymfoblastic Leukamia (ALL), receive Erwinase-injections i.m. (cytostatika: killing leukamia cells) in the fifth week, for 10 consecutive days.
Aim:
To test the following hypotheses: (1) The children will experience significantly less pain and (2) significantly less anxiety when receiving Xylocain in the needle before Erwinase, compared to placebo (normal saline) before Erwinase.
Design:
An experimental study (randomized, doubleblinded, placebo-controlled, cross over).
Subjects:
12 children were included (June 1996 until December 1998). The childrens' age was median 5.5 years (range 4–12 years).
Criteria for participation were:
1) Newly diagnosed children with ALL, 2) Norwegian speaking children and parents, 3) Age from 4 years.
Participation
was 75% (12/16).
Procedures:
On one of the two first days of the Erwinase course, the children received 0.5 ml Xylocain (10 mg/ml) through the needle. After 0,5 minute Erwinase was given (1 minute injection). The other day they received 0.5 ml placebo before Erwinase (median 1.2 ml, range 0.95 – 1.90 ml) (10 000 E in 0.5ml normal saline). All received Lidocaine-Prilocaine emulsion, EMLA).
Instruments:
Three different self-rating Faces Pain Scales (FPS) were used. The anchoring points were: no pain and most pain possible (Baker and Wong, Bieri, Kuttner and Lepage). We also used a Kuttner and Lepage scale, suitable to rate anxiety. The children were interviewed.
Analysis:
Wilcoxon one sample test was used to test the hypotheses, and Spearman rank correlation was used for some additional analyses.
Results:
When the children had experienced both types of injections, they rated the procedure where Xylocain was used before Erwinase injections, as significantly less