Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Tonsillectomy or Adeno-tonsillectomy in Children

Overview

Postoperative pain following tonsillectomy or adeno-tonsillectomy in children is severe and sometimes last for days. Sufentanil is used by epidural route for postoperative analgesia in children. There are few reports about its use for postoperative analgesia by continuous intravenous infusion. Its complications include , hypoxia, sedation, pruritus ,nausea and/or vomiting. The investigators design this protocol to test efficacy of analgesia of three different rates of continuous intravenous sufentanil infusion for postoperative pain management following coblation tonsillectomy or adeno-tonsillectomy in children. The investigators also compare incidence rate of complications for three groups.

Full Title of Study: “Comparison of Three Different Rates of Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Coblation Tonsillectomy or Adeno-tonsillectomy in Children”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 2014

Interventions

  • Drug: continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion
  • Drug: continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion
  • Drug: continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion

Arms, Groups and Cohorts

  • Experimental: Sufentanil infusion rate 0.02μg•kg-1•h-1
    • Sufentanil infusion rate 0.02μg•kg-1•h-1 lasted for 48 hours
  • Experimental: Sufentanil infusion rate 0.03μg•kg-1•h-1
    • Sufentanil infusion rate 0.03μg•kg-1•h-1 lasted for 48 hours
  • Experimental: Sufentanil infusion rate 0.04μg•kg-1•h-1
    • Sufentanil infusion rate 0.04μg•kg-1•h-1 lasted for 48 hours

Clinical Trial Outcome Measures

Primary Measures

  • objective pain score
    • Time Frame: up to 48 hours after operation

Secondary Measures

  • incidence rate of hypoxia
    • Time Frame: 4h,8h,24h,48h after operation

Participating in This Clinical Trial

Inclusion Criteria

  • American Society of Anesthesiologists grade I or II children aged 5-8 years undergoing coblation tonsillectomy or adeno-tonsillectomy as in-patient Exclusion Criteria:

  • Children with a history of adverse reaction to opioids, long-term use of opioid medications, and history of chronic pain. – Psychiatric illness, kidney failure, hypotension, atrioventricular block, myasthenia gravis etc.

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 8 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jin Ni
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jin Ni, Department of Anesthesiology – Guangzhou Women and Children’s Medical Center
  • Overall Official(s)
    • Jin Ni, M.D., Principal Investigator, Guangzhou Women and Children’s Medical Center

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