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

NCT02205580 | Unknown Phase 4 DMC

• 1 other identifier: GZWCMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Breathing Disorders; Tonsillitis; Adenoid Hypertrophy

Outcome Measures

Primary Outcomes (1)

• objective pain score

  up to 48 hours after operation

Secondary Outcomes (1)

• incidence rate of hypoxia

  4h,8h,24h,48h after operation

Other Outcomes (3)

• incidence rate of pruritus

  4h,8h,24h,48h after operation

• incidence rate of nausea and/or vomiting

  4h,8h,24h,48h after operation

• incidence rate of sedation

  4h,8h,24h,48h after operation

Study Arms (3)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Interventions

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

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

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

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

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

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

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jin Ni: lead

Study Sites (1)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510623, China

Location

MeSH Terms

Conditions

Tonsillitis

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jin Ni, M.D.

  Guangzhou Women and Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology

Study Record Dates

• First Submitted: July 26, 2014
• First Posted: July 31, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 30, 2014

Record last verified: 2014-09

Locations

CN (1)