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

Jin Ni

Status and phase: Unknown; Phase 4

Conditions: Sleep Breathing Disorders; Tonsillitis; Adenoid Hypertrophy

Treatments: Drug: continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion; Drug: continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion; Drug: continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02205580

GZWCMC

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 8 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

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

Experimental group

Description:

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

Treatment:

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

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

Experimental group

Description:

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

Treatment:

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

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

Experimental group

Description:

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

Treatment:

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