Analgesic Effects of Gabapentin and Paracetamol

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Dow University of Health Sciences

ASSAIG CLÍNIC: NCT04068506

BioSeek: nct04068506

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Resum

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.

Descripció

Gabapentin is an anti-convulsion medication and has a high affinity for voltage-gated calcium channel throughout the brain, acts by inhibition of release of excitatory neurotransmitters. As a lipophilic substance, it shows linear pharmacokinetics and has oral bioavailability greater than 90%. Gabapentin is used in a variety of condition as a therapeutic measure involving diabetic neuropathy, post-herpetic neuralgia, in partial seizures, restless leg syndrome, post-menopausal hot flashes, anxiety, resistant mood disorders, essential tremors, and numerous other modalities. Gabapentin is a muscle relaxant and anti-spasmodic, its analgesic effect has also be identified for moderate to severe pain.

Dates

Darrera verificació:	12/31/2019
Primer enviat:	11/10/2018
Inscripció estimada enviada:	08/22/2019
Publicat per primera vegada:	08/27/2019
Última actualització enviada:	01/21/2020
Publicació de l'última actualització:	01/26/2020
Data d'inici de l'estudi real:	08/31/2019
Data estimada de finalització primària:	01/06/2020
Data estimada de finalització de l’estudi:	01/20/2020

Condició o malaltia

Hand Injuries

Intervenció / tractament

Drug: Gabapentin 600 mg Tab

Fase

Fase 4

Grups de braços

Braç	Intervenció / tractament
Experimental: Group A Gabapentin 600 mg Tab
Active Comparator: Group B Paracetamol 1000 mg Tab

Criteris d'elegibilitat

Edats elegibles per estudiar	18 Years Per a 18 Years
Sexes elegibles per estudiar	All
Accepta voluntaris saludables	Sí
Criteris	1. Inclusion Criteria: 1. Patients between 18-60 years of age 2. Patients Undergoing hand surgery in the Department of Plastics and Reconstructive Surgery, Dr. Ruth KM Pfau Civil Hospital Karachi, Dow University of Health Sciences 2. Exclusion criteria: 1. Pregnant women 2. Any patient presenting with the signs of: - Arrhythmia - Myocardial ischemia - Cognitive impairment - Psychiatric disorders - Drug abuse 3. Patients sensitive to any epileptic drug or taking any anti-epileptic drug 4. Having severe and multiple injuries.

Resultat

Mesures de resultats primaris

1. Comparison of analgesic effects of Gabapentin and paracetamol in patients with hand injury [6 months]

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.

Analgesic Effects of Gabapentin and Paracetamol

Paraules clau

ansietat

tremolor essencial

neuropatia diabètica

neuràlgia

tremolor

seizures

antifúngic

analgèsic

antiespasmòdic