Comparison of Analgesic Effects of Gabapentin and Paracetamol in Patients With Hand Injury
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Comparison of analgesic effects of Gabapentin and paracetamol in patients with hand injury
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Exclusion criteria:
- •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.
排除标准
- 未提供
研究组 & 干预措施
Group A
Gabapentin 600 mg Tab
干预措施: Gabapentin 600 mg Tab (Drug)
Group B
Paracetamol 1000 mg Tab
干预措施: Gabapentin 600 mg Tab (Drug)
结局指标
主要结局
Comparison of analgesic effects of Gabapentin and paracetamol in patients with hand injury
时间窗: 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.
次要结局
未报告次要终点
研究者
Hyder Ali
assistant professor
Dow University of Health Sciences