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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep Breathing Disorders, Tonsillitis, Adenoid Hypertrophy

Intervention / Treatment
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* Drug: continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion
* Drug: continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion
* Drug: continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sufentanil infusion rate 0.02μg•kg-1•h-1<br>Sufentanil infusion rate 0.02μg•kg-1•h-1 lasted for 48 hours | Drug: continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion<br> <br> |
| Experimental: Sufentanil infusion rate 0.03μg•kg-1•h-1<br>Sufentanil infusion rate 0.03μg•kg-1•h-1 lasted for 48 hours | Drug: continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion<br> <br> |
| Experimental: Sufentanil infusion rate 0.04μg•kg-1•h-1<br>Sufentanil infusion rate 0.04μg•kg-1•h-1 lasted for 48 hours | Drug: continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective pain score |  | up to 48 hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence rate of hypoxia |  | 4h,8h,24h,48h after operation |