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临床试验/NCT03902249
NCT03902249已完成4 期

Effect of Intravenous Dexamethasone in Combination With Pudendal Nerve Block on Postoperative Pain Control in Pediatric Hypospadias Repair

Dr Sonia ben khalifa (PhD)0 个研究点目标入组 70 人开始时间: 2017年1月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Patients who received 0.15mg/kg of Dexamethasone in 8ml of saline

干预措施: Dexamethasone (Drug)

Placebo group

Placebo Comparator

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

发起方
Dr Sonia ben khalifa (PhD)
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr Sonia ben khalifa (PhD)

Clinical Professor

Hôpital d'enfants Béchir-Hamza

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