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

Tonsillitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02205580
• Other study ID #: GZWCMC
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: July 26, 2014
• Last updated: September 28, 2014
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: September 2014
• Source: Guangzhou Women and Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 8 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenoid Hypertrophy
• Hypertrophy
• Pain, Postoperative
• Sleep Breathing Disorders
• Tonsillitis

Intervention

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

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

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

Locations

Country	Name	City	State
China	Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jin Ni

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	incidence rate of pruritus		4h,8h,24h,48h after operation	Yes
Other	incidence rate of nausea and/or vomiting		4h,8h,24h,48h after operation	Yes
Other	incidence rate of sedation		4h,8h,24h,48h after operation	Yes
Primary	objective pain score		up to 48 hours after operation	No
Secondary	incidence rate of hypoxia		4h,8h,24h,48h after operation	Yes