Abstract
PurposeEffect size estimates of analgesic drugs can be misleading. Ibuprofen (400 mg, 600 mg, 800 mg), paracetamol (1000 mg, 500 mg), paracetamol 1000 mg/codeine 60 mg, and placebo were investigated to establish the multidimensional pharmacodynamic profiles of each drug on acute pain with calculated effect size estimates.MethodsA randomized, double-blind, single-dose, placebo-controlled, parallel-group, single-centre, outpatient, and single-dose study used 350 patients (mean age 25 year, range 18 to 30 years) of homogenous ethnicity after third molar surgery. Primary outcome was sum pain intensity over 6 h. Secondary outcomes were time to analgesic onset, duration of analgesia, time to rescue drug intake, number of patients taking rescue drug, sum pain intensity difference, maximum pain intensity difference, time to maximum pain intensity difference, number needed to treat values, adverse effects, overall drug assessment as patient-reported outcome measure (PROM), and the effect size estimates NNT and NNTp.ResultsIbuprofen doses above 400 mg do not significantly increase analgesic effect. Paracetamol has a very flat analgesic dose–response profile. Paracetamol 1000/codeine 60 mg gives similar analgesia as ibuprofen from 400 mg, but has a shorter time to analgesic onset. Active drugs show no significant difference in maximal analgesic effect. Other secondary outcomes support these findings. The frequencies of adverse effects were low, mild to moderate in all active groups. NNT and NTTp values did not coincide well with PROMs.ConclusionIbuprofen doses above 400 mg for acute pain offer limited analgesic gain. Paracetamol 1000 mg/codeine 60 mg is comparable to ibuprofen doses from 400 mg. Calculated effect size estimates and PROM in our study seem not to relate well as clinical analgesic efficacy estimators.Trial registrationNCT00699114.
Highlights
Numbers needed to treat (NNT) are frequently used as a measure of the clinical efficacy of analgesics on acute postoperative pain [1]
There was a significant difference in analgesic efficacy between ibuprofen and paracetamol irrespective of doses
Paracetamol 1000 mg combined with codeine 60 mg was comparable to ibuprofen in doses from and above 400 mg
Summary
Numbers needed to treat (NNT) are frequently used as a measure of the clinical efficacy of analgesics on acute postoperative pain [1]. European Journal of Clinical Pharmacology profile of analgesics including time-related variables, and patient-reported outcome measures (PROM) The objective of this multidimensional study was to investigate the relative clinical pharmacodynamic profiles of commonly used doses of ibuprofen, paracetamol, paracetamol with codeine, versus placebo using the well documented dental impaction model with balanced entry pain and an ethnically homogenous study population [7]. We compared these profiles with the calculated NNT values of the respective analgesics in this test model. The clinical relevance of this multidimensional study was to establish minimum drug doses with maximum benefit to avoid unnecessary overdosing or suboptimal dosing of these types of analgesics when used for postoperative pain after limited surgical interventions
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