The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain: A Prospective Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- post tonsillectomy pain
研究概览
简要总结
The aim of this study is to compare the efficacy of adding paracetamol to systemic non-steroidal anti-inflammatory drugs (NSAIDs) versus adding dexamethasone as local infiltration to paracetamol on post tonsillectomy pain control.
详细描述
A Prospective Randomized Controlled study. The study will be conducted at Ain Shams University hospital, Otolaryngology Department. Study period is 6 months from approval of the protocol. Study Participants will be recruited from outpatient ENT clinic, and ENT department inpatients.
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
- Single (Participant)
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Between 4-10 years.
- •Indications of tonsillectomy such as:
- •Recurrent acute attacks at least 7 episodes in the past year or at least 5 episodes per year for 2 years or at least 3 episodes per year for 3 years.
- •Chronic tonsillitis and hypertrophy of tonsils causing sleep apnea, difficulty in deglutition, interference in speech.
- •Tonsillectomy by cold dissection only.
- •American Society of Anesthesiologists (ASA) classification 1,2 (Normal Health, Mild systematic disease).
排除标准
- •Patients with age less than 4 and more than 10 years.
- •Indications of tonsillectomy other than chronic tonsillitis such as lymphoma.
- •Patients on chronic steroid therapy
- •Hemoglobin level less than 10 gm/dL
- •Presence of acute infection in the upper respiratory tract, acute tonsillitis
- •American Society of Anesthesiologists (ASA) classification ASA 3,4 (Severe systematic disease such as uncontrolled Diabetes, cardiac disease, liver or kidney disease, life threating medical conditions)
- •Regular use of analgesics within a week of surgery.
研究组 & 干预措施
1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and par
1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and par
干预措施: Dexamethasone (Procedure)
2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and ant
2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol.
干预措施: NSAIDs (Drug)
3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsill
3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsill
干预措施: Control (Standard treatment) (Drug)
结局指标
主要结局
post tonsillectomy pain
时间窗: DAY 0 6h, 24h post-operatively and DAY 5 post-operatively
The primary endpoints that will be used is resting pain scores using virtual analogue scale; VAS score (0: no pain-10: worst pain) at DAY 0 after 6h, 24h and DAY 5 post-operatively. Where pain score will be measured at multiple points during the outcome intervals, the pain scores at the time closest to six and 24h will be used.
次要结局
- Additional pain medication needed(2 weeks post operatively)
- Pt feedback after tonsillectomy(2 weeks post operatively)
- Complications(2 weeks post operatively)