Evidence map›Paper›PMID 31929374›Full record

Trial reportJournal of orthopaedic trauma2020

Intravenous Ibuprofen Reduces Opioid Consumption During the Initial 48 Hours After Injury in Orthopedic Trauma Patients.

Russell D Weisz, Alexander A Fokin, Vivian Lerner, Amy Flynt, Ines Macias-Perez, Leo Pavliv, Maggie Crawford, Ivan Puente

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of orthopaedic trauma, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.2field-weighted citation impact, top 12% 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.

NCT02152163 phase4completednot on this map

Assessing the Efficacy of IV Ibuprofen for Treatment of Pain in Orthopedic Trauma Patients

TypeinterventionalSponsorDelray Medical CenterRan2012 to 2018Enrolled99ConditionsPainArmsIV Ibuprofen, placebo
NCT03671746 phase1completednot on this map

Inflammatory Response to Trauma - Does Early Cytokine Modulation Improve Patient Outcome

TypeinterventionalSponsorArun AnejaRan2019 to 2023Enrolled70ConditionsPolytraumaArmsKetorolac, Saline Solution
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 17 citations in OpenAlex.

  1. Review
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  3. Article
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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

8 authors at 2 institutions in 1 country.

Russell D WeiszDelray Medical Center, Delray Beach, FL.
Alexander A FokinDelray Medical Center, Delray Beach, FL.
Vivian LernerDelray Medical Center, Delray Beach, FL.
Amy FlyntPharPoint Research, Durham, NC; and.
Ines Macias-PerezCumberland Pharmaceuticals, Nashville, TN.
Leo PavlivCumberland Pharmaceuticals, Nashville, TN.
Maggie CrawfordDelray Medical Center, Delray Beach, FL.
Ivan PuenteDelray Medical Center, Delray Beach, FL.
Delray Medical Center · USCumberland Pharmaceuticals (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the efficacy of intravenous (IV) ibuprofen (Caldolor) administration in the management of acute pain in orthopedic trauma patients and to minimize opioid use.

designRandomized controlled trial, double-blind, parallel, placebo-controlled.

settingLevel 1 Trauma Center. PATIENTS: A total of 99 consecutive orthopedic trauma patients with fractures of the ribs, face, extremities, and/or pelvis were randomized to receive either 800 mg IV ibuprofen (53 patients) or placebo (44 patients) administered every 6 hours for a total of 8 doses within 48 hours of admission and the same PRN medications along with 20-mg IV/PO Pepcid twice a day. To establish pain reduction efficacy, the analysis was consequently performed in the modified intent-to-treat group that included 74 randomized subjects with a baseline pain score greater than 2. The primary outcomes were reduction in opioid consumption and decrease in pain intensity (PI).

interventionAdministration of study medications. OUTCOME MEASUREMENTS: PI measured by Numerical Rating Scale, opioid consumption adjusted to morphine equivalent dose, and time to first narcotic administration.

resultsThe 2 groups had comparable baseline characteristics: age, sex distribution, mechanism of injury, type of injury, injury severity score, and PI. IV ibuprofen statistically significantly reduced opioid consumption compared with placebo during the initial 48-hour period (P = 0.017). PI calculated as PI differences was statistically different only at 8-hour interval after Caldolor administration. Time to first narcotic medication was significantly longer in the Caldolor group (hazard ratio: 1.640; 95% confidence interval, 1.009-2.665; P = 0.046).

conclusionsIV ibuprofen provided adequate analgesia, prolonged time to first narcotic administration, and was opioid-sparing for the treatment of pain in orthopedic trauma patients, which makes Caldolor a recommended candidate for managing acute pain in the diverse orthopaedic trauma population. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Indexed as

Analgesics, Non-NarcoticIbuprofenAdministration, IntravenousAnalgesics, OpioidDouble-Blind MethodHumansPostoperative PainTreatment OutcomeAnalgesics, Non-NarcoticAnalgesics, OpioidIbuprofen

Identifiers

PMID31929374
PMCPMC7274153
OpenAlexW2999774674

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.