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

IRGC-04-NI-17-099

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.

2022-10-16

2023-02-21

2023-02-21

Completed

Early phase I

162

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Combination 1- Diclofenac Placebo Paracetamol (Oral) Combination 2- Diclofenac Paracetamol (IV) Placebo Combination 3- Diclofenac Placebo Placebo', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 162, 'type': 'ACTUAL'}}

2023-03-01