1. Journal Club by Dr Mohammad Al-Busafi R4

2.  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 1 st 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.  Randomised, double-blind,multidose, trial  Data collected prospectively by the child & family in 1 st 72 hrs after disharge from ED  Conducted in a children’s hospital Level 1 trauma center ED between August 2003 & September 2007

4.  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.  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

8.  Daily diary for data collection given to parents and children  Daily data collection and returned in stamped envelope  Two standard telephone calls during 1 st 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 !!

9.  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

13.  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 %

14.  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

15.  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?

16. 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?

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

18. 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 %

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

20. 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

21. 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?