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

NCT ID: NCT02205580

Last Updated: 2014-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Breathing Disorders Tonsillitis Adenoid Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sufentanil infusion rate 0.02μg•kg-1•h-1

Sufentanil infusion rate 0.02μg•kg-1•h-1 lasted for 48 hours

Group Type EXPERIMENTAL

continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion

Intervention Type DRUG

Sufentanil infusion rate 0.03μg•kg-1•h-1

Sufentanil infusion rate 0.03μg•kg-1•h-1 lasted for 48 hours

Group Type EXPERIMENTAL

continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion

Intervention Type DRUG

Sufentanil infusion rate 0.04μg•kg-1•h-1

Sufentanil infusion rate 0.04μg•kg-1•h-1 lasted for 48 hours

Group Type EXPERIMENTAL

continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion

Intervention Type DRUG

Interventions

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continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion

Intervention Type DRUG

continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion

Intervention Type DRUG

continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jin Ni

OTHER

Sponsor Role lead

Responsible Party

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Jin Ni

Department of Anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jin Ni, M.D.

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Women and Children's Medical Center

Locations

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Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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GZWCMC

Identifier Type: -

Identifier Source: org_study_id