Evidence map›Paper›PMID 40940161›Full record

SynthesisCanadian family physician Medecin de famille canadien2025

Tramadol (with or without acetaminophen) efficacy and harm: Systematic review and meta-analysis.

Jessica A Otte, Gloria Chu, Benji Heran, Ken Bassett

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in Canadian family physician Medecin de famille canadien, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Jessica A OtteEducator and researcher for the Therapeutics Initiative, Associate Member of the Division of Palliative Care, and Clinical Associate Professor in the Department of Family Medicine, all in the Faculty of Medicine at the University of British Columbia (UBC) in Vancouver. Jessica.otte@ubc.ca.
Gloria ChuPharmacist and Researcher in the Drug Assessment Working Group of the Therapeutics Initiative at UBC.
Benji HeranCo-chair of the Drug Assessment Working Group as part of the Therapeutics Initiative at UBC.
Ken BassettCo-managing Director of the Therapeutics Initiative, Professor in the Department of Family Practice, and Associate Member in the Department of Anesthesiology, Pharmacology and Therapeutics, all at UBC.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of tramadol (with or without acetaminophen) in adult pain management compared with nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and acetaminophen alone. DATA SOURCES: Studies were identified through a search of the entire Ovid MEDLINE database, the Ovid MEDLINE Epub Ahead of Print database, Embase, and Evidence-Based Medicine Reviews (Cochrane Central Register of Controlled Trials) from 1946 to August 19, 2022. STUDY SELECTION: Included studies comprised double-blind, randomized controlled trials (RCTs) of oral tramadol (with or without acetaminophen) compared with opioids, NSAIDs, or acetaminophen for treatment of acute or chronic pain that reported at least 1 of 11 outcomes: total adverse events (AEs), fatal serious AEs (SAEs), nonfatal SAEs, patient withdrawals from the study due to AEs (WDAEs), total study withdrawals, measures of dependence or addiction, quality of life, functional improvement, 30% or more pain reduction, 50% or more pain reduction, and rescue medication use. Overall, 3184 articles were screened and 37 RCTs (21 opioid, 15 NSAID, 1 acetaminophen; N=7156; length 1 hour to 12 weeks) were included. Trials were critically appraised and assessed using the Cochrane risk of bias tool for randomized trials 1.0. Meta-analyzed outcomes were reported as risk ratios (with 95% confidence intervals [CIs]). SYNTHESIS: Compared with opioids, tramadol with or without acetaminophen did not significantly differ in efficacy based on 50% or more or 30% or more reduction in pain or in any harm outcomes (nonfatal SAEs [risk ratio (RR)=1.35, 95% CI 0.43 to 4.20]; WDAEs [RR=0.99, 95% CI 0.80 to 1.22]; total withdrawals [RR=0.93, 95% CI 0.78 to 1.11]; or total AEs [RR=0.97, 95% CI 0.89 to 1.05]). Compared with NSAIDs, tramadol with or without acetaminophen was less likely to achieve a 30% or more reduction in pain (RR=0.82, 95% CI 0.76 to 0.90), and was more likely to result in WDAEs (RR=2.86, 95% CI 2.23 to 3.66), total withdrawals (RR=1.68, 95% CI 1.47 to 1.93), and total AEs (RR=1.37, 95% CI 1.28 to 1.47). Evidence was insufficient for meta-analysis of fatal SAEs, drug dependence or addiction, quality of life, functional improvement, or use of rescue medications.

conclusionTramadol with or without acetaminophen did not differ significantly from other opioids, and was less effective and more poorly tolerated than NSAIDs. Short study duration, small sample size, extensive patient exclusion, and inconsistency in outcome reporting limit the scientific validity of conclusions.

Indexed as

AcetaminophenAnalgesics, OpioidChronic PainTramadolAdultAnalgesics, Non-NarcoticAnti-Inflammatory Agents, Non-SteroidalDrug Therapy, CombinationHumansPain ManagementRandomized Controlled Trials as TopicAcetaminophenAnalgesics, Non-NarcoticAnalgesics, OpioidAnti-Inflammatory Agents, Non-SteroidalTramadol

Identifiers

PMID40940161
PMCPMC12454558

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.