Randomised Controlled Trial of Ibuoprofen Versus Acetaminophen With Codeine for Acute Pediatric Arm - PowerPoint PPT Presentation

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Randomised Controlled Trial of Ibuoprofen Versus Acetaminophen With Codeine for Acute Pediatric Arm

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Data collected prospectively by the child & family in 1st 72 hrs after disharge from ED ... Larger or less doses could ve given more analgesia ... – PowerPoint PPT presentation

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Title: Randomised Controlled Trial of Ibuoprofen Versus Acetaminophen With Codeine for Acute Pediatric Arm


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

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 childrens 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 gt 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

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8
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 / acetaminophencodeine
  • Physician ,parent ,all researhers blinded to
    treatement
  • Unblinded only if need 4 rescue RX ( opposite RX
    , i.e ibuprofen /acetaminophencodeine ) ( 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

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  • 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
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

15
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?

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?

22
END
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