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

September 28, 2014 updated by: Jin Ni

Comparison of Three Different Rates of Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Coblation Tonsillectomy or Adeno-tonsillectomy in Children

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510623
        • Guangzhou Women And Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 8 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sufentanil infusion rate 0.02μg•kg-1•h-1
Sufentanil infusion rate 0.02μg•kg-1•h-1 lasted for 48 hours
Drug: continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion
Experimental: Sufentanil infusion rate 0.03μg•kg-1•h-1
Sufentanil infusion rate 0.03μg•kg-1•h-1 lasted for 48 hours
Drug: continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion
Experimental: Sufentanil infusion rate 0.04μg•kg-1•h-1
Sufentanil infusion rate 0.04μg•kg-1•h-1 lasted for 48 hours
Drug: continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
incidence rate of pruritus
Time Frame: 4h,8h,24h,48h after operation
4h,8h,24h,48h after operation
incidence rate of nausea and/or vomiting
Time Frame: 4h,8h,24h,48h after operation
4h,8h,24h,48h after operation
incidence rate of sedation
Time Frame: 4h,8h,24h,48h after operation
4h,8h,24h,48h after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jin Ni

Investigators

  • Principal Investigator: Jin Ni, M.D., Guangzhou Women And Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

July 26, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (Estimate)

July 31, 2014

Study Record Updates

Last Update Posted (Estimate)

September 30, 2014

Last Update Submitted That Met QC Criteria

September 28, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZWCMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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