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

Phase 4

• Conditions: Sleep Breathing Disorders; Adenoid Hypertrophy; Tonsillitis
• Interventions: Drug: continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion; Drug: continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion; Drug: continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion

• Registration Number: NCT02205580
• Lead Sponsor: Jin Ni

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2014-07-26
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Status Verified: 2014-09
• Study Start: 2014-09
• Last Update Submitted: 2014-09-28
• Last Update Posted: 2014-09-30
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sufentanil infusion rate 0.03μg•kg-1•h-1	continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion	Sufentanil infusion rate 0.03μg•kg-1•h-1 lasted for 48 hours
Sufentanil infusion rate 0.04μg•kg-1•h-1	continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion	Sufentanil infusion rate 0.04μg•kg-1•h-1 lasted for 48 hours
Sufentanil infusion rate 0.02μg•kg-1•h-1	continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion	Sufentanil infusion rate 0.02μg•kg-1•h-1 lasted for 48 hours

Primary Outcome Measures

Name	Time	Method
objective pain score	up to 48 hours after operation

Secondary Outcome Measures

Name	Time	Method
incidence rate of hypoxia	4h,8h,24h,48h after operation

Trial Locations

Locations (1)

Guangzhou Women and Children's Medical Center; 🇨🇳 Guangzhou, Guangdong, China