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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02205580

Enrollment

Registered

2014-07-31

Start date

2014-09-30

Completion date

2014-12-31

Last updated

2014-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoid Hypertrophy, Sleep Breathing Disorders, Tonsillitis

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.

Interventions

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

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 8 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
objective pain score	up to 48 hours after operation

Secondary

Measure	Time frame
incidence rate of hypoxia	4h,8h,24h,48h after operation

Other

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026