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

NCT04199572 | Completed Phase 4 DMC

• 1 other identifier: IRGC-04-NI-17-099
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Musculoskeletal Injury

Outcome Measures

Primary Outcomes (1)

• To compare the difference in mean pain reduction amongst the three groups: numerical rating scale

  Pain score on a numerical rating scale (NRS). The scale is a 11 point scale where 0 is no pain and 10 is the worst pain ever.

  30 minutes

Secondary Outcomes (4)

• To compare the difference in proportion of patients achieving 50% or more pain relief amongst the three groups

  30 minutes

• Requirement of rescue analgesia in each group of participants

  30 minutes

• The adverse event rate in three groups

  90 minutes

• Time to analgesia effect, to achieve 50% reduction, and to NRS <=2

  90 minutes

Study Arms (3)

Diclofenac and Oral Paracetamol

EXPERIMENTAL

Diclofenac (75mg intramuscular), Placebo (100ml intravenous Normal Saline), Paracetamol (per oral 1gm)

Drug: Diclofenac and Paracetamol

Diclofenac and IV Paracetamol

EXPERIMENTAL

Diclofenac (75mg intramuscular), Paracetamol (intravenous1gm in 100ml solution), Placebo (sugar tablets)

Drug: Diclofenac and Paracetamol

Diclofenac and Placebo

EXPERIMENTAL

Diclofenac (75mg intramuscular),Placebo (100ml intravenous Normal Saline),Placebo (sugar tablets)

Drug: Diclofenac and Paracetamol

Interventions

Diclofenac and Paracetamol DRUG

analgesic effect of diclofenac along with either Oral versus Intravenous paracetamol versus placebo

Also known as: Placebo

Diclofenac and IV Paracetamol; Diclofenac and Oral Paracetamol; Diclofenac and Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years upto 65 years
• Vitals Stable
• musculoskeletal limb injury
• initial pain score of 5 or more on a NRS (numerical rating scale)

You may not qualify if:

• Patient received any pain medication prior to 8 hours
• Allergies to either diclofenac or paracetamol
• Contraindication to the study drugs
• CVA
• Bronchial asthma
• GI bleeding
• Renal impairment
• Asthma
• Pregnancy and nursing
• Unstable traumatic patient

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation

Doha, 3050, Qatar

Location

Related Publications (19)

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  PMID: 41623940 DERIVED

MeSH Terms

Interventions

Diclofenac; Acetaminophen

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The physicians, participants, nurses and the outcome assessor will all be blinded to the intervention. The trial packets will be prepared containing the active drugs and placebos.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Research Associate

Model Details: Combination 1- Diclofenac Placebo Paracetamol (Oral) Combination 2- Diclofenac Paracetamol (IV) Placebo Combination 3- Diclofenac Placebo Placebo

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start: October 16, 2022
• Primary Completion: February 21, 2023
• Study Completion: February 21, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)