Analgesic Effects of Gabapentin and Paracetamol

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StatussPabeigts

Sponsori

Dow University of Health Sciences

KLĪNISKĀ IZPĒTE: NCT04068506

BioSeek: nct04068506

Atslēgvārdi

Abstrakts

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.

Apraksts

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.

Datumi

Pēdējoreiz pārbaudīts:	12/31/2019
Pirmais iesniegtais:	11/10/2018
Paredzētā reģistrācija iesniegta:	08/22/2019
Pirmais izlikts:	08/27/2019
Pēdējais atjauninājums iesniegts:	01/21/2020
Pēdējā atjaunināšana ievietota:	01/26/2020
Faktiskais studiju sākuma datums:	08/31/2019
Paredzamais primārās pabeigšanas datums:	01/06/2020
Paredzamais pētījuma pabeigšanas datums:	01/20/2020

Stāvoklis vai slimība

Hand Injuries

Iejaukšanās / ārstēšana

Drug: Gabapentin 600 mg Tab

Fāze

Fāze 4

Roku grupas

Roka	Iejaukšanās / ārstēšana
Experimental: Group A Gabapentin 600 mg Tab
Active Comparator: Group B Paracetamol 1000 mg Tab

Atbilstības kritēriji

Vecums, kas piemērots studijām	18 Years Uz 18 Years
Dzimumi, kas ir piemēroti studijām	All
Pieņem veselīgus brīvprātīgos	Jā
Kritēriji	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.

Rezultāts

Primārie rezultāti

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

Atslēgvārdi

nemiers

essential tremor

diabētiskā neiropātija

neuralgia

tremor

seizures

pretsēnīšu

pretsāpju līdzeklis

spazmolītisks