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Journal Club by Dr Mohammad Al-Busafi R4

Journal Club by Dr Mohammad Al-Busafi R4. Randomised Controlled Trial of Ibuoprofen Versus Acetaminophen With Codeine for Acute Pediatric Arm Fracure Annals of Emergency Medicine October 2009. Objective. Compare efficacy of Ibuprofen 10 mg /kg

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Journal Club by Dr Mohammad Al-Busafi R4

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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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