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Randomized comparative

trial of efficacy ofparacetamol, ibuprofen andparacetamol-ibuprofencombination for treatmentof febrile children

Critical Appraisal for Therapy Articles

Fermana Saputra, dr.

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What question did the study ask?

P=Patients pasien anak dengan demam tanpa komplikasiI=Intervention

pengobatan dengan paracetamol

C=Comparison pengobatan dengan ibuprofen pengobatan dengan kombinasi paracetamol-

ibuprofenO=Outcome

lebih cepat menurunkan panas

Apakah pengobatan dengan paracetamol padapasien anak dengan demam tanpa komplikasi lebihcepat dalam menurunkan panas dibandingkanpengobatan dengan ibuprofen, atau dengan

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Was the assignment of patients totreatments randomised?

This was investigator blind,randomized, parallel group, multiplearm comparative , single dose trialcarried out at Pediatrics department of atertiary care teaching hospital.

Yes, randomized

Based on computer generatedrandomization , block randomizationwas used to assign three sequences to33 subjects in each group in the ratio of1:1:1.

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Were the groups similar at the startof the trial?

Terdapat group baseline yg hampir sama padaweight, height, dan baseline temperatureBaseline age dan gender tidak terlalu samaSecara statistik tidak signifikan, karena p>0.05

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Aside from the allocated treatment, weregroups treated equally?

For ibuprofen 10 mg/kg or paracetamol 15mg/kg or both ibuprofen and paracetamol,with the help of calibrated measuring cylinderwith 60 ml of water.Primary study objective was the reduction inthe tympanic temperature from the baselinetemperature at the end of 4 h after drugadministration.

Afebrile children at 1, 2, 3 and 4 h post dose,

any adverse drug events occurring during the4 h period were recorded.

Yes, differrent groups were treatedequally.

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Were measures objective or were the patients andclinicians kept blind to which treatment was beingreceived?

This was investigator blind.Participants were allocated by theunblinded investigator to one of thethree treatment arms.

Double blind design would have beenideal but would have been complicatedand not likely to be acceptable byparticipants hence investigator blinddesign was considered.

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WHAT WERE THERESULTS?

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How large was the treatmenteffect?

There was a significant difference between threegroups ( P = 0.013 ), maximum reduction intemperature in combination group andminimum in paracetamol group .

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Post-hoc multiple comparisontest between the three groups

Untuk menghitung relative risk Antara PCT-Ibuprofen, PCT-Kombinasi, Ibuprofen-Kombinasi

Persentase pasien menjadi afebrissetelah 4 jam di tiap grup: PCT: 76.66 % Ibuprofen: 78.12 % Kombinasi: 93.54 %

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Between paracetamol andcombination group ( P = 0.03)

Pasien menjadi afebris setelah 4 jam RR = T/K = 0.93/ 0.76 = 1.22

Since the RR > 1, the treatment increases the

afebrile patients. ARR = K-T = -0.17

The absolute benefit of treatment is a 17%increase in afebrile patients.

RRR = 1-RR = -0.22The treatment increase the afebrile patient by22% relative to that occurring in thePCT/control group.

NNT = 1/ARR = -5.88

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No significant difference betweenibuprofen and the combination group ( P= 0.167), or

Between paracetamol and ibuprofengroup ( P = 0.102).

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How precise was the estimateof the treatment effect?

In this study, the difference intemperature reduction between twogroups (PCT & Combination) although

statistically significant ( P = 0.013 ), wasnot clinically significant less than 1C(0.71C).

2.19 1.48 = 0.71 C

CI [?]

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Will the results help me incaring for my patient?

Is my patient so different to those inthe study that the results cannotapply? No, it isnt This study population is Indian children

Is the treatment feasible in my setting? Yes, it is Walaupun sediaan kombinasi PCT-

Ibuprofen dengan dosis yg disesuaikan

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Will the potential benefits of treatment

outweigh the potential harms oftreatment for my patient? Yes, it will If quicker reduction in body temperature is

the goal of therapy.

Both antipyretics have been found to beequally safe in children.[9]

PCT should be used preferentially due to alower risk of adverse effects.[6,10]

Ibuprofen has the advantage of less frequentdose (every 6-8 h vs. every 4 h for PCT).[11]