Transcript Randomised Controlled Trial of Ibuoprofen Versus

Journal Club by
Dr Mohammad Al-Busafi R4
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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
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 Treatment failure of assigned drug and use of rescue
medication
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Also compare
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Pain scores
Pain-related functional limitations
Adverse effects
satisfction
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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
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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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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
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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 !!
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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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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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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?
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?
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 %
Absolute Risk Reduction (ARR):
The absolute arithmetic difference
in events rate .
ARR= EER – CER
=20.3 % -31% = 10.7 %
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
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?