Comparison of Analgesic Efficacy of Topical Tramadol Versus Topical Lidocaine in the Control of Post Operative Pain in Children After Tonsillectomy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- modified visual analogue pain score (m-VAS)
研究概览
简要总结
Tonsillectomy is considered one of the most frequent minor surgeries conducted on a day-case basis on children, and usually associated with pain and sore throat. This study aimed to include 80 children, ASA physical status I&II aged 4-15 years, and undergoing tonsillectomy. The purpose of this study is to determine the analgesic efficacy of topically applied lidocaine and tramadol in relieving post-operative pain in children following tonsillectomy.
详细描述
Pain and sore throat following tonsillectomy are typical. As a result, the issue of adequate post-tonsillectomy pain management remains a significant therapeutic obstacle. Several medications, including nonsteroidal anti-inflammatory drugs, corticosteroids and narcotics have been utilised to alleviate pain following tonsillectomy. Nevertheless, they have numerous undesirable negative consequences. NSAIDs may impede hemostasis and increase the propensity for bleeding. Opioid may result in respiratory depression, nausea, and vomiting. Consequently, the major purpose of this study is pain alleviation with minimal adverse effects.
This prospective, randomized, double-blind controlled clinical study will include 80 children, undergoing tonsillectomy, to receive either topical tramadol 5% or lidocaine 2%. Modified Visual Analogue Scale (m-VAS), bleeding, nausea, vomiting, sore throat, otalgia, fever, halitosis, and constipation will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent acute tonsillitis
- •Chronic tonsillitis
- •Tonsillar hypertrophy with or without obstructive sleep apnea
排除标准
- •Parent refusal
- •Hypersensitivity
- •History of bronchial asthma
- •Renal impairment
- •Impaired liver function
- •Bleeding disorders
研究组 & 干预措施
Tramadol group
Swabs soaked with tramadol 5% 2 mg/kg diluted with saline 0.9%
干预措施: Tramadol 5% (Drug)
Tramadol group
Swabs soaked with tramadol 5% 2 mg/kg diluted with saline 0.9%
干预措施: Lidocaine 2% (Drug)
Lidocaine group
Swabs soaked with lidocaine 2% 2mg /kg diluted with saline 0.9%
干预措施: Tramadol 5% (Drug)
Lidocaine group
Swabs soaked with lidocaine 2% 2mg /kg diluted with saline 0.9%
干预措施: Lidocaine 2% (Drug)
结局指标
主要结局
modified visual analogue pain score (m-VAS)
时间窗: "day 7" after surgery
It is 0-10 scale, color-coded (blue to red) scale. The scale also included depictions of faces, from happy to sad. Zero indicates no pain, 1-3 indicates mild pain, 4-7 indicates moderate pain, and 8-10 indicates severe agony.
次要结局
- Halitosis(Within 7 days after surgery)
- Fever(Within 7 days after surgery)
- Otalgia(Within 7 days after surgery)
- Trismus(Within 7 days after surgery)
- Time to first oral fluid intake(Within the first day after surgery)
- Post-tonsillectomy bleeding(Within 7 days after surgery)
- Time to first ibuprofen rescue analgesia(Within 7 days after surgery)
- Time to first oral solid intake(Within the first day after surgery)
- Postoperative nausea and vomiting(Within 7 days after surgery)
研究者
Abdelwahab Saleh
Professor of Anesthesia, Intensive Care, and Pain Management
Al-Azhar University