Effect of Intravenous Dexamethasone in Combination With Pudendal Nerve Block on Postoperative Pain Control in Pediatric Hypospadias Repair
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 主要终点
- number of rescue analgesic consumption
研究概览
简要总结
This study aims to determine if intravenous Dexamethasone combined with a pudendal nerve block is able to prolong postoperative analgesia in children undergoing hypospadias repair.
详细描述
It was a prospective study, randomized, double blind study, conducted at the Tunis Children's Hospital (January 2017-December 2018). After agreement with parents and the local ethics committee, the investigators included children aged 1 to 18 years, ASA 1-2, proposed for a hypospadias repair. Patients were randomized to: Group D receiving 0. 15mg/kg of Dexamethasone IV after induction and group P receiving the same volume of saline. The pudendal block was performed by neurostimulation after induction with Sevoflurane and 3 gamma/kg Fentanyl IV. The success of the block was tested at 10 and 15 minutes, it was declared successful when the systolic blood pressure and heart rate did not increase by more than 20% compared to the baseline values at the time of the incision. No analgesics were administered at the end of the surgery. The pain was assessed by the CHEOPS score the first 24 hours. The X2 test was used for qualitative variables and the student test for quantitative variables with P<0. 05 as the significance threshold. The number of patients required for the study was calculated (alpha=5% beta=90%) and was 62.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 1 Year 至 18 Years(Child, Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA physical status classification 1 or 2
- •Procedure: hypospadias repair
- •Eligible for a pudendal nerve block
排除标准
- •parents or patient refusal
- •nerve block failure
- •Peroperative complication.
研究组 & 干预措施
Dexamethasone group
Patients who received 0.15mg/kg of Dexamethasone in 8ml of saline
干预措施: Dexamethasone (Drug)
Placebo group
Patients who received the same volume of saline as the study group (8ml)
干预措施: Dexamethasone (Drug)
结局指标
主要结局
number of rescue analgesic consumption
时间窗: The first 24 hours after surgery
Total number of rescue analgesic consumption for each patient
The mean time to first rescue analgesic
时间窗: The first 24 hours after surgery
Time from the end of surgery to the first administration of rescue analgesic
次要结局
- pain scores (CHEOPS)(Hour 0, Hour 1, Hour 2, Hour 3, Hour 4, Hour 8, Hour 12, Hour 24)
- Number of episodes of postoperative nausea and vomiting(The first 24 hours after surgery)
研究者
Dr Sonia ben khalifa (PhD)
Clinical Professor
Hôpital d'enfants Béchir-Hamza
