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Codeine for Pediatric Patients with Acute Pain: A Review of Clinical Effectiveness

Last updated: November 15, 2019
Project Number: RC1200-000
Product Line: Rapid Response
Research Type: Drug
Report Type: Summary with Critical Appraisal
Result type: Report

Question

  1. What is the clinical effectiveness of codeine for pediatric patients with acute pain?
  2. What is the clinical effectiveness of codeine with acetaminophen for pediatric patients with acute pain?

Key Message

One systematic review was identified regarding the clinical effectiveness of codeine or codeine with acetaminophen, three randomized controlled trials (RCT) were identified regarding the clinical effectiveness of codeine with acetaminophen, and one non-randomized study was identified regarding the clinical effectiveness of codeine. For the clinical effectiveness of codeine, the included systematic review2 compared codeine to acetaminophen or ibuprofen; no difference was found between groups for minor AEs, including nausea, sleepiness and constipation (however it was unclear if between-group differences were compared statistically). For comparisons with codeine plus acetaminophen, the included systematic review showed significantly higher rates of adverse events in the codeine plus acetaminophen group versus the ibuprofen group in a single RCT. The first included RCT, the patients in the codeine plus acetaminophen group had lower pain and distress compared to the acetaminophen group during restraint and needle aspiration of tympanocentesis. In the second included RCT, codeine plus acetaminophen was significantly less effective for play and eating functional outcomes. In the third included RCT, between-group differences were not tested statistically but pain scores were numerically similar between the acetaminophen and ibuprofen group. In the non-randomized study, there were no significant differences between patients treated with codeine and patients treated with hydrocodone for adverse events.