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Comparison of Ibuprofen vs. Acetaminophen with Codeine in Pediatric Arm Fracture Pain Management

This study compares the efficacy of Ibuprofen and Acetaminophen with Codeine for outpatient treatment of pediatric arm fracture pain. The randomized trial analyzed treatment failure, pain scores, functional limitations, and adverse effects. Results showed a lower failure rate for Ibuprofen but not statistically significant. Critical appraisal and risk reduction analysis were performed.

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Comparison of Ibuprofen vs. Acetaminophen with Codeine in Pediatric Arm Fracture Pain Management

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  1. Journal Club by Dr Mohammad Al-Busafi R4 Randomised Controlled Trial of Ibuoprofen Versus Acetaminophen With Codeine for Acute Pediatric Arm FracureAnnals of Emergency Medicine October 2009

  2. Objective • Compare efficacy of • Ibuprofen 10 mg /kg • Paracetamol and codeine ( cocodamol! ) 1mg/kg (codeine component ) • For outpatient treatment of pain in Paeds patients in the 1st 72 hours after injury • Primary outcome • Treatment failure of assigned drug and use of rescue medication • Also compare • Pain scores • Pain-related functional limitations • Adverse effects • satisfction

  3. Study design • Randomised , double-blind ,multidose , trial • Data collected prospectively by the child & family in 1st 72 hrs after disharge from ED • Conducted in a children’s hospital Level 1 trauma center ED between August 2003 & September 2007

  4. Inclusion criteria • Children 4-18 yrs old • Dx w # radius,ulna or humerus visualised on standard 2-view radiograph • All # confirmed by pediatric radiographer • # not requiring reduction or manipulation

  5. Exclusion Criteria • Children weighing > 60 kg ( requiring larger doses • h/o GI bleed/ulcer , low platelets , bleeding disorder ,kidney disease , uncontrolled chronic disease ,allergy to paracetamol or regular use • Inability to understand English

  6. intervention • Daily diary for data collection given to parents and children • Daily data collection and returned in stamped envelope • Two standard telephone calls during 1st 72 hrs • Random-number table used to assign patients to ibuprofen / acetaminophen+codeine • Physician ,parent ,all researhers blinded to treatement • Unblinded only if need 4 rescue RX ( opposite RX , i.e ibuprofen /acetaminophen+codeine ) ( 1hour after giving study RX • Blinding for color , volume not taste !!

  7. Children and care givers given diary to record whether play , school affected by pain • Record of side effects • Parents satisfaction recorded daily with 0 to 5 Likert scale • On day 3 modified Total Quality Pain Management instrucment used to measure parent and child satisfaction

  8. Primary outcome was failure of the assigned study medication , leading to use of rescue medication • ibuprofen was 20.3 % less than acetaminophen w codeine of 31.0 % • Statistically not signficiant 10.7 % at Confidence interval of 95 %

  9. limitations • No record kept of patient eligible for inclusion in study during reasercher absence so larger numbers could ‘ve been included • Doses of Rx used were based on local institution so ? Larger or less doses could ‘ve given more analgesia • Parents gave Rx to children on their own discretion

  10. Critical Appraisal • Was the allocation of Pts randomized? • Was the allocation concealed? • Were the Pts in the two groups similar at the start of the trial with respect to prognostic factors? • Were Pts analysed in the groups to which they were randomized?

  11. Blinding : • Were Pts aware of group allocation? • Were clinicians aware of group allocation? • Were outcome assessors aware of group allocation? • Were statisticians aware of group allocation?

  12. Were the follow up of Pts sufficiently long & complete?

  13. Relative Risk Reduction (RRR): Proportional reduction in rates of bad events between experimental & control group in trial . RRR =(EER-CER)/CER =(20.3 % -31.0 % ) /31.0% = 34.5 %

  14. Absolute Risk Reduction (ARR): The absolute arithmetic difference in events rate . ARR= EER – CER =20.3 % -31% = 10.7 %

  15. Number Need to Treat ( NNT ): The number of Pts who need to be treated to achieve one additional favourable outcome. NNT = 1/ ARR =1/10.7 % = 9.34

  16. Will the results help me in caring for my Pts? • Were the study Pts similar to Pts in my care? • Were all clinically important outcomes considered? • Are the likely benefits worth the potential harms & costs?

  17. END

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