NCT04199572

Synergistic Effect Of Parenteral Diclofenac And Paracetamol In The Pain Management Of Acute Limb Injuries

Completed Phase 4 Last updated 1 March 2023

What this trial tests

Phase 4 trial testing Diclofenac and Paracetamol in Musculoskeletal Injury in 162 participants. Completed in 21 February 2023.

Timeline

16 October 2022

Primary endpoint
21 February 2023

21 February 2023

Quick facts

Lead sponsor	Hamad Medical Corporation
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	162
Start date	16 October 2022
Primary completion	21 February 2023
Estimated completion	21 February 2023
Sites	1 location across Qatar

Drugs / interventions tested

• Diclofenac and Paracetamol — full drug profile →

Conditions studied

• Musculoskeletal Injury — all drugs for Musculoskeletal Injury →

Sponsor

Hamad Medical Corporation — full company profile →

Who can join

Adults 18 to 65, any sex, with Musculoskeletal Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute limb injury is a common reason to visit an emergency department worldwide. Intense pain related to the injury is always a concern for an emergency physician and requires effective analgesia within the shortest possible time. Non-steroidal anti-inflammatory drugs (NSAIDs), opioids and paracetamol are the commonly used drugs in an emergency department. The choice of analgesia should be established by its efficacy, logistics involved and route of administration. There is good evidence about NSAIDs being the first line analgesia and paracetamol is reported to have the narcotic sparing effect, either alone or as an adjunctive treatment in different settings. The synergistic effect of paracetamol with diclofenac in acute limb injuries related pain management lacks good- quality evidence. Therefore investigators proposed a large, well designed, randomized double-blind trial to develop high-quality evidence. The study aims to assess the efficacy of paracetamol in addition to diclofenac, and compare the difference between oral and intravenous paracetamol administration in acute limb injuries in the emergency department.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Randomized Trial Evaluating the Synergistic Effect of Parenteral Diclofenac and Paracetamol for Pain Management in Adult Males With Acute Limb Injury.
   Qureshi I, S Qureshi R, Harris T, A Pathan S, et al · · 2026 · PMID 41623940 · DOI 10.1155/prm/5587917