Analgesic Effects of Gabapentin and Paracetamol

NCT04068506 | Completed Phase 4 DMC

• 1 other identifier: 123
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hand Injuries

Outcome Measures

Primary Outcomes (1)

• Comparison of analgesic effects of Gabapentin and paracetamol in patients with hand injury

  The outcome of this study will be finding that how much gabapentin is effective in improving pain over paracetamol by simply inquiring about the analgesic effect of both drugs with the help of Visual analogue scale measuring pain intensity from 1 - 10 and how much each drug adversely effects individual's health by assessment of any unwanted symptoms like: nausea, vomiting, headache, dizziness, etc. So, that certainty about its effect and efficacy over paracetamol in relieving pain can be assessed.

  6 months

Study Arms (2)

Group A

EXPERIMENTAL

Gabapentin 600 mg Tab

Drug: Gabapentin 600 mg Tab

Group B

ACTIVE COMPARATOR

Paracetamol 1000 mg Tab

Drug: Gabapentin 600 mg Tab

Interventions

Gabapentin 600 mg Tab DRUG

Gabapentin 600 mg Tab is a drug of choice for treating postoperative pain.

Also known as: Neurontin

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients between 18-60 years of age
• Patients Undergoing hand surgery in the Department of Plastics and Reconstructive Surgery, Dr. Ruth KM Pfau Civil Hospital Karachi, Dow University of Health Sciences

You may not qualify if:

• Pregnant women
• Any patient presenting with the signs of:
• Arrhythmia
• Myocardial ischemia
• Cognitive impairment
• Psychiatric disorders
• Drug abuse
• Patients sensitive to any epileptic drug or taking any anti-epileptic drug
• Having severe and multiple injuries.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dr. Ruth K.M. Pfau Civil Hospital Karachi

Karachi, Sindh, Pakistan

Location

Related Publications (1)

• Ali H; Naveed; Perveen B. Comparison of analgesic effects of Gabapentin and Paracetamol post-operatively in patients with hand injury. J Pak Med Assoc. 2021 Nov;71(11):2501-2505. doi: 10.47391/JPMA.359.

  PMID: 34783725 DERIVED

Related Links

• Improving the Quality of Care Through Pain Assessment and Management.
• A descriptive study of hand injuries presenting to the adult emergency department of a tertiary care center in urban India.
• Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged.
• Gabapentin in Acute Postoperative Pain Management
• Pain as a factor complicating recovery and discharge after ambulatory surgery.
• Prescribing gabapentin off label: Perspectives from psychiatry, pain and neurology specialists
• Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection

MeSH Terms

Conditions

Hand Injuries

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Hyder Ali, MBBS,FCPS

  Assistant professor at Dr.Ruth K.M pfau Civil Hospital Karachi,DUHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators will divide the calculated sample size into two groups A and B in which all the participants have the same probability of being included in the study. Two unrecognizable envelopes separating both drugs gabapentin and paracetamol with equivalent dose will be administered with the specific code number labeled by the principal investigator and will be prescribed by the on-duty doctor to the patients in tablet form once orally allowed after surgery. Analgesic effects will be inquired after 6 hours of drug administration. Further questions will be asked according to the questionnaire by the co-investigators having no knowledge of the given drug to participant.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: A total of 50 patients who fulfill the inclusion criteria will be approached and written consent will be signed by the participants prior to the interview. Participants will be divided into two groups divided equally i.e. gabapentin group and paracetamol group. Gabapentin group received 600 mg dose while the control/other group received 1 gram (1000 mg) of paracetamol as a postoperative analgesic agent.

Study Record Dates

• First Submitted: November 11, 2018
• First Posted: August 28, 2019
• Study Start: September 1, 2019
• Primary Completion: January 7, 2020
• Study Completion: January 21, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)