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

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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

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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

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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

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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

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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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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 !!

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• 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

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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

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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?

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• 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?

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• Were the follow up of Pts sufficiently long
  complete?

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• 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

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• Absolute Risk Reduction (ARR)
• The absolute arithmetic difference in events rate
  .
• ARR EER CER
• 20.3 -31 10.7

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• 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

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• 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?

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END