Clonidine and Morphine in Caudal Anesthesia

Study Overview
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Brief Summary
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Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better postoperative analgesia than either drug alone after urogenital pediatric surgery.

Detailed Description
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It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, submitted to urogenital surgery, under general anesthesia and caudal block. The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine, bupivacaine plus morphine, bupivacaine plus clonidine and morphine. The peroperative consumption of analgesics and inhaled gases, BIS, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using Wong-Baker faces scale and pain and discomfort score scale, as well as the consumption of analgesics.

Official Title
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Comparison of Clonidine and Morphine Plus Bupivacaine in Caudal Peridural Anesthesia for Postoperative Analgesia After Pediatric Urogenital Surgery

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Clonidine
* Drug: Morphine
* Drug: Bupivacaine plus clonidine and morphine
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Urogenital pediatric surgery Status physical(ASA) 1 and 2 Exclusion Criteria: Cutaneous infection in puncture site

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B<br>compare caudal anesthesia with bupivacaine alone or in addition to morphine, clonidine or both | Drug: Bupivacaine<br>* Caudal anesthesia with bupivacaine 0,166% 1 ml/kg<br>|
| Active Comparator: C<br>compare caudal anesthesia with bupivacaine plus clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or morphine plus clonidine | Drug: Clonidine<br>* 1 mcg/kg<br>|
| Active Comparator: M<br>compare caudal anesthesia with bupivacaine plus morphine with caudal anesthesia with bupivacaine alone or in addition to clonidine or morphine plus clonidine | Drug: Morphine<br>* 20 mcg/kg<br>|
| Active Comparator: CM<br>compares caudal anesthesia with bupivacaine, morphine and clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or clonidine | Drug: Bupivacaine plus clonidine and morphine<br>* bupivacaine 0,166% 1 ml/kg clonidine 1 mcg/kg morphine 20 mcg/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The overall postoperative consumption of analgesics. |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The peroperative consumption of volatile anesthetics. |  | 3 hours | 
| The peroperative Bispectral Index measure. |  | 3 hours | 
| Postoperative Wong-Baker faces scale |  | 24 hours | 
| Postoperative pain and discomfort score scale |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caudal anesthesia, clonidine, morphine, bupivacaine