Evidence map›Paper›PMID 32683644›Full record

ArticlePain and therapy2020

Efficacy and Safety of Intravenously Administered Tramadol in Patients with Moderate to Severe Pain Following Bunionectomy: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study.

Neil K Singla, Richard Pollak, Ira Gottlieb, David Leiman, Harold Minkowitz, John Zimmerman, Mark Harnett, Michael Ryan, Lucy Lu, Scott Reines

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pain and therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03290378 (A Phase 3, Multicenter, Randomized, Double Blind, Three-Arm Study to Evaluate the Efficacy and Safety of Tramadol Infusion), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.4field-weighted citation impact, top 18% of its field
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.

NCT03290378 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double Blind, Three-Arm Study to Evaluate the Efficacy and Safety of Tramadol Infusion (AVE-901) Versus Placebo in the Management of Postoperative Pain Following Bunionectomy

TypeinterventionalSponsorAvenue Therapeutics, Inc.Ran2017 to 2018Enrolled409ConditionsPain ManagementArmsTramadol, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. 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

10 authors at 3 institutions in 1 country.

Neil K SinglaLotus Clinical Research, Pasadena, CA, USA.
Richard PollakEvolution Research Group, New Providence, NJ, USA.
Ira GottliebChesapeake Research Group, Pasadena, MD, USA.
David LeimanHD Research, Bellaire, TX, USA.
Harold MinkowitzHD Research, Bellaire, TX, USA.
John ZimmermanTrovare Clinical Research, Bakersfield, CA, USA.
Mark HarnettAvenue Therapeutics, New York, NY, USA.
Michael RyanAvenue Therapeutics, New York, NY, USA.
Lucy LuAvenue Therapeutics, New York, NY, USA. llu@avenuetx.com.
Scott ReinesAvenue Therapeutics, New York, NY, USA.
Chesapeake Research Group · USLotus Clinical Research · USProvidence College · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis study is part of the registrational program for intravenously administered (IV) tramadol in the USA and compared the analgesic benefit and tolerability of two doses of IV tramadol (50 mg and 25 mg) to placebo in adult patients undergoing bunionectomy, an orthopedic surgical model.

methodsThis was a phase 3, multicenter, double-blind, three-arm, randomized, placebo-controlled, multiple-dose, parallel-group trial to evaluate IV tramadol in the management of postoperative pain following bunionectomy. Eligible patients were randomized (1:1:1 ratio) to IV tramadol 50 mg, 25 mg, or placebo. Primary endpoint was summary of pain intensity differences over 48 h (SPID48). Key secondary endpoints included SPID24, total consumption of rescue analgesia, and patient global assessment of efficacy (PGA). Safety assessments included treatment emergent adverse events (TEAEs), clinical laboratory tests, vital signs, and electrocardiograms (ECGs). Assessment of the dose-response was an important objective of the study.

resultsThe study established a dose response, with IV tramadol 50 mg demonstrating statistically significant benefit (p < 0.05) over placebo for primary and all key secondary efficacy endpoints, whereas tramadol 25 mg demonstrated intermediate results between the 50 mg and placebo arms. IV tramadol 50 mg was well tolerated; most common TEAEs were nausea and vomiting; and there were no meaningful differences among treatments for vital signs, ECG, and laboratory assessments. The largest proportion of patients completed tramadol 50 mg (98.6%) compared to tramadol 25 mg (91.8%) and placebo (88.2%).

conclusionIV tramadol 50 mg was effective and well tolerated as treatment for postoperative pain following bunionectomy surgery, while IV tramadol 25 mg, although well tolerated, was judged an ineffective dose for the treatment of pain in this setting. IV tramadol 50 mg was further developed in the registrational program for the USA.

trial registrationClinicalTrials.gov identifier, NCT03290378.

Indexed as

Dose-findingIntravenously administered tramadolPostoperative painRandomized clinical trialSchedule IV opioidSummary of pain differences

Identifiers

PMID32683644
PMCPMC7648778
OpenAlexW3043553833

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Registered trials

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.