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临床试验/NCT06359925
NCT06359925尚未招募不适用

Comparative Study Between Dexmedetomidine Plus Bupivacaine Versus Bupivacaine in Suprazygomatic Maxillary Nerve Block for Management of Postoperative Pain in Tonsillectomy Patients.

Assiut University0 个研究点目标入组 80 人开始时间: 2024年10月22日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
time and amount of first postoperative rescue analgesia after two different blocks using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score

研究概览

简要总结

The use of suprazygomatic maxillary nerve block to reduce postoperative pain and hospital stay is greater than the use of NSAID and opioids.

详细描述

Tonsillectomy is one of the most commonly performed operations worldwide, with postoperative pain being the main cause of morbidity . Unlike most other surgeries, tonsillectomies leave an open wound that heals by secondary intention. Thermal and mechanical injuries lead to inflammation, nerve irritation, and spasms of the pharyngeal muscles that can result in severe pain Because, this procedure is performed primarily on an outpatient basis, postoperative complications, including pain, vomiting, fever, and hemorrhage, can significantly lengthen recovery room stays and lead to emergency department visits and unanticipated hospital admission.

Poorly controlled posttonsillectomy pain can result in decreased oral intake, dysphagia, dehydration, and weight loss. Standard management of postoperative pain following tonsillectomy includes acetaminophen, hydrocodone or oxycodone, and nonsteroidal anti-inflammatory drugs .

Despite scheduled administration of analgesics, postoperative pain is often poorly controlled .

Opioid use and preoperative pain at or remote from the surgical site have been demonstrated to be associated with a higher risk of persistent postoperative pain ,and large cohort studies have reported concerning rates of long-term postoperative opioid use after minor surgery in previously opioid-naı¨ve patients .

Efforts to reduce opioid use, particularly after hospital discharge, require further attention; thus opioid consumption beyond the early postoperative period is an increasingly important outcome measure .

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
None

入排标准

年龄范围
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 3-10 years old
  • The American Society of Anesthesiologists (ASA) I and II
  • Children scheduled for tonsillectomy with or without adenoidectomy.

排除标准

  • Patient's guardian refusal to participate in the study.
  • Children with Behavioural changes; physical or developmental delay; neurological disorder or psychological disorder.
  • Children on sedative or anticonvulsant medication.
  • Bleeding diathesis
  • History of sleep apnea
  • Significant organ dysfunction.
  • cardiac dysrhythmia.
  • congenital heart disease .
  • Known allergy to the study drugs.
  • Skin lesions or wounds at the puncture site of the proposed block

结局指标

主要结局

time and amount of first postoperative rescue analgesia after two different blocks using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score

时间窗: 24 hours

Postoperative pain will be recorded using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) scores at admission to the PACU \[0\] minutes (baseline), \[30 \]minutes, \[1\], \[4\], \[8\],\[ 12\], \[18\] and \[24\] hours postoperatively. where the minimum score of zero (no pain) and the maximum score of 12 (the most severe pain). Children with the modified CHEOPS \[ ≥ 5 \]will be given supplemental analgesia with IV paracetamol 15 mg/kg , Pain scores will be recorded 15-20 minutes following the administration of this supplemental analgesia to assess pain relief. The number of children that required postoperative rescue analgesics, the first time to rescue analgesia, and the total amount of rescue analgesia consumed within \[24\] hours postoperatively will be recorded.

次要结局

  • Parents satisfaction score(24 hours)
  • time and amount of first postoperative rescue analgesia after two different blocks using Paediatric Anaesthesia Emergence Delirium (PAED) scale(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Asaad Hasan Rizk

Assistant Lecturer

Assiut University

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