Evidence map›Paper›PMID 27382251›Full record

ArticleDrug design, development and therapy2016

Double-blind, randomized, double-dummy clinical trial comparing the efficacy of ketorolac trometamol and naproxen for acute low back pain.

Pérola Grinberg Plapler, Morton Aaron Scheinberg, Christina da Cunha Ecclissato, Monalisa Fernanda Bocchi de Oliveira, Roberto Bleuel Amazonas

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

Article in Drug design, development and therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01471886 (Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
1.2field-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.

NCT01471886 phase3completednot on this map

Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment

TypeinterventionalSponsorEMSRan2013 to 2013Enrolled83ConditionsBack PainArmsKetorolac Tromethamine, Naproxen
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Non-steroidal anti-inflammatory drugs for acute low back pain.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Review
  4. Multimodal Analgesia in the Aesthetic Plastic Surgery: Concepts and Strategies.Plastic and reconstructive surgery. Global open · 2022
    Article
  5. Article
  6. 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

5 authors at 2 institutions in 1 country.

Pérola Grinberg PlaplerOrthopedic and Traumatology Institute of Clinical Hospital, University of São Paulo, Brazil.
Morton Aaron ScheinbergClinical Research Center Hospital AACD, São Paulo, Brazil.
Christina da Cunha EcclissatoNC Group Medical Affairs, Hortolândia, São Paulo, Brazil.
Monalisa Fernanda Bocchi de OliveiraNC Group Medical Affairs, Hortolândia, São Paulo, Brazil.
Roberto Bleuel AmazonasNC Group Medical Affairs, Hortolândia, São Paulo, Brazil.
Celestica (Brasil) · BRUniversidade de São Paulo · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNonsteroidal anti-inflammatory drugs (NSAIDs) are the most common type of medication used in the treatment of acute pain. Ketorolac trometamol (KT) is a nonnarcotic, peripherally acting nonsteroidal anti-inflammatory drug with analgesic effects comparable to certain opioids.

objectiveThe aim of this study was to compare the efficacy of KT and naproxen (NA) in the treatment of acute low back pain (LBP) of moderate-to-severe intensity. PATIENTS AND

methodsIn this 10-day, Phase III, randomized, double-blind, double-dummy, noninferiority trial, participants with acute LBP of moderate-to-severe intensity as determined through a visual analog scale (VAS) were randomly assigned in a 1:1 ratio to receive sublingual KT 10 mg three times daily or oral NA 250 mg three times daily. From the second to the fifth day of treatment, if patient had VAS >40 mm, increased dosage to four times per day was allowed. The primary end point was the reduction in LBP as measured by VAS. We also performed a post hoc superiority analysis.

resultsKT was not inferior to NA for the reduction in LBP over 5 days of use as measured by VAS scores (P=0.608 for equality of variance; P=0.321 for equality of means) and by the Roland-Morris Disability Questionnaire (P=0.180 for equality of variance test; P=0.446 for equality of means) using 95% confidence intervals. The percentage of participants with improved pain relief 60 minutes after receiving the first dose was higher in the KT group (24.2%) than in the NA group (6.5%; P=0.049). The most common adverse effects were heartburn, nausea, and vomiting.

conclusionKT is not inferior in efficacy and delivers faster pain relief than NA.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalDouble-Blind MethodHumansKetorolacLow Back PainNaproxenTromethamineAnti-Inflammatory Agents, Non-SteroidalKetorolacNaproxenTromethamineacute low back painketorolac trometamolnaproxennonsteroidal anti-inflammatory drugs

Identifiers

PMID27382251
PMCPMC4918732
OpenAlexW2442818427

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.