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NCT04068506: GABA

Analgesic Effects of Gabapentin and Paracetamol

Completed Phase 4 Last updated 27 January 2020
What this trial tests

Phase 4 trial testing Gabapentin 600 mg Tab in Hand Injuries in 68 participants. Completed in 21 January 2020.

Timeline
1 September 2019
Primary endpoint
7 January 2020
21 January 2020

Quick facts

Lead sponsorDow University of Health Sciences
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposesupportive care
Enrollment68
Start date1 September 2019
Primary completion7 January 2020
Estimated completion21 January 2020
Sites1 location across Pakistan

Drugs / interventions tested

Conditions studied

Sponsor

Dow University of Health Sciences

Who can join

Adults 18 to 60, any sex, with Hand Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This research is about the effects of drug gabapentin; which is an amino acid that is structurally similar to neurotransmitter GABA. It is a novel drug used for the treatment of postoperative pain with analgesic properties having unique mechanism of action. This study reviews clinical effects of this agent in hand injury patients managed at the Department of Plastics \& Reconstructive Surgery, Dow University of Health Sciences \& Dr. Ruth KM Pfau Civil Hospital Karachi. This study aims to inquire the analgesic properties of gabapentin in the patients and to further investigate its comparison with the equivalent dose of paracetamol given 6 hours after undergoing operative procedure. Acetaminophen is well tolerated when administered in therapeutic dose for pain management. It is a principal drug used as pain reliever and as an antipyretic regimen. This is an experimental study in which a pre-coded questionnaire would be approved in the research for appraising the intensity of pain after intervening operative procedure using visual analogue scale, measuring the pain intensity from 0-10. The questions regarding pain intensity will be inquired after administrating the drug six hours postoperatively. The drug will be prescribed by the doctor on duty having no knowledge regarding the given drug or the group in which he/she is administrating the drug; further questionnaire will be filled by the two co-investigators who will be trained by principal investigator, how to take correct information. Sample size was calculated using www.openepi.com using the previous literature searches of similar research and 50 patients (25 in each group) will be randomly selected from the ward of a known case of hand injury. Group A patients will receive 600 mg of gabapentin post operatively while group B will receive 1 g of paracetamol for management of pain postoperatively orally.

Publications & conference data

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

  1. Comparison of analgesic effects of Gabapentin and Paracetamol post-operatively in patients with hand injury.
    Ali H, Naveed, Perveen B. · · 2021 · PMID 34783725 · DOI 10.47391/jpma.359

Verify or expand the search:

Other recruiting trials for Hand Injuries

Currently open trials in the same condition.

Other Dow University of Health Sciences trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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