Evidence map›Paper›PMID 32021411›Full record

ArticleJournal of pain research2020

Safety, Tolerability, and Effect on Opioid Use of Meloxicam IV Following Orthopedic Surgery.

Kipling P Sharpe, Richard Berkowitz, William A Tyndall, David Boyer, Stewart W McCallum, Randall J Mack, Wei Du

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of pain research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02720692 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety of N1539 Following Major Surgery), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 19% 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.

NCT02720692 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety of N1539 Following Major Surgery

TypeinterventionalSponsorBaudax BioRan2016 to 2017Enrolled722ConditionsPain, Post-operativeArmsN1539, Intravenous Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
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

7 authors at 3 institutions in 1 country.

Kipling P SharpeOrthoArizona, Gilbert, AZ, USA.
Richard BerkowitzPhoenix Clinical Research, Tamarac, FL, USA.
William A TyndallUniversity Orthopedics Center, Altoona, PA, USA.
David BoyerShoals Clinical Research Associates, LLC, Florence, SC, USA.
Stewart W McCallumBaudax Bio, Inc., Malvern, PA, USA.ORCID 0000-0001-7550-5845
Randall J MackBaudax Bio, Inc., Malvern, PA, USA.
Wei DuClinical Statistics Consulting, Blue Bell, PA, USA.
Arizona Research Center · USClinical Research Associates · USUniversity Orthopedics Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveA Phase 3 randomized multicenter, double-blind, placebo-controlled trial (NCT02720692) compared once-daily intravenous (IV) meloxicam 30 mg to placebo, when added to the standard of care pain management regimens, in adults with moderate-to-severe pain following major elective surgery and concluded that meloxicam IV had a safety profile similar to placebo and reduced opioid consumption.

methodsIn this post hoc subgroup analysis of orthopedic surgery subjects, 379 subjects received meloxicam IV 30 mg or IV-administered placebo every 24 hrs for ≤7 doses. Safety was assessed via AEs, laboratory tests, vital signs, and ECG, with an emphasis on specific AEs, including injection site reactions, bleeding, cardiovascular, hepatic, renal, thrombotic, and wound healing events. Daily opioid consumption was assessed during treatment.

resultsAmong meloxicam IV-treated subjects, 64.7% experienced ≥1 AE versus 68.8% of placebo-treated subjects. Investigators assessed most AEs to be mild or moderate in intensity and unrelated to treatment. Total opioid consumption (36.8 mg versus 50.3 mg IV morphine equivalent dose;

conclusionMeloxicam IV demonstrated no significant differences in the number and frequency of AEs versus placebo in subjects following orthopedic surgery. Opioid consumption was reduced in the meloxicam IV group versus placebo.

trial registrationClinicalTrials.gov (Identifier: NCT02720692).

Indexed as

meloxicam IVNSAIDorthopedic surgerypostoperative painsafety

Identifiers

PMID32021411
PMCPMC6982445
OpenAlexW2999058995

What OpenQuestion holds

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LicenceCC BY-NC
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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.