Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Comparison of the Analgesic Efficacy and Safety of Intravenous Ketoprofen, Tramadol, and Morphine After Bony Impacted Mandibular Third Molar Surgery
Bibliographic record
Abstract
Introduction Although opioids remain the standard of care for managing postsurgical pain, concerns persist regarding their safety, tolerability, and potential for addiction. Intravenous (IV) formulations of ketoprofen and tramadol have been widely available in numerous countries outside the United States and Canada. Methods This single-dose, single-center, double-blind, randomized study (n=185) evaluated the analgesic efficacy, dose-response relationship, duration of action, and safety of IV ketoprofen 50 mg (n=33) and 100 mg (n=31), IV tramadol 100 mg (n=33) and 150 mg (n=22), IV morphine 4 mg (n=33), and placebo (n=33) administered over two minutes upon the first occurrence of moderate-to-severe pain following surgical extraction of bony impacted mandibular third molars. Pain intensity and pain relief were assessed over eight hours. The primary efficacy endpoint was total pain relief over the first four hours (TOTPAR 0-4). Secondary efficacy endpoints included TOTPAR at additional time intervals, summed pain intensity difference (SPID), peak pain relief, peak pain intensity difference, time to rescue analgesia, patient global evaluation, and time to confirmed perceptible and meaningful pain relief. Safety assessments included volunteered and observed adverse events (AEs). Results For TOTPAR 0-4 and all other efficacy endpoints, IV ketoprofen 50 mg and 100 mg, and IV tramadol 100 mg and 150 mg were significantly superior to IV morphine 4 mg and placebo. IV ketoprofen at both doses also outperformed IV tramadol at both doses across the majority of outcome measures. No significant differences in efficacy were observed between IV morphine 4 mg and placebo. The proportion of subjects experiencing one or more AEs was comparable among the placebo, IV ketoprofen 50 mg, and IV ketoprofen 100 mg groups. In contrast, higher AE rates were reported in the IV tramadol and IV morphine groups relative to placebo. Dosing in the IV tramadol 150 mg group was discontinued early due to the occurrence of seizures in two patients (9%) immediately following administration. Conclusions Both IV ketoprofen and IV tramadol demonstrated superior analgesic efficacy compared to IV morphine and placebo in the management of postsurgical pain. Notably, IV ketoprofen consistently outperformed tramadol across efficacy endpoints. The lack of efficacy observed with IV morphine 4 mg raises concerns about potential analgesic assay insensitivity in postsurgical dental pain. The occurrence of seizures in subjects without known seizure risk factors highlights a potentially insufficient safety margin for tramadol in unselected patient populations.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.002 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".