Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery

Study Overview
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Brief Summary
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The use of increasing doses of clonidine ssociated to bupivacaine in caudal epidural block provides better postoperative analgesia compared whit analgesia provide by bupivacaine alone It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity , cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable.

Detailed Description
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It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity, cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable. Postoperative hemodynamics parameters will be recordes at 24 h.

Official Title
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Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Clonidine 1 mcg/Kg
* Drug: Clonidine 2 mcg/ Kg
* Drug: Clonidine 3 mcg/ Kg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CHildren 1 - 10 years old. ASA I E II ( American Society of Anesthesiology) hypospadias surgery Exclusion Criteria: parents refuse Infection Coagulation disorders Allergy to anesthetics Abnormalities of the sacral spine

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

Sexes Eligible for Study
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Male

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Bupivacaine 0,166%<br>General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% for hypospadia surgery | |
| Active Comparator: Clonidine 1 mcg/Kg<br>IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 1 mcg/ Kg of clonidine for hypospadia surgery | Drug: Clonidine 1 mcg/Kg<br>* Clonidine 1 mcg/Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery<br>* Other names: Atensine;|
| Active Comparator: Clonidine 2 mcg/ Kg<br>IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 2 mcg/ Kg of clonidine for hypospadia surgery | Drug: Clonidine 2 mcg/ Kg<br>* Clonidine 2 mcg//Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery<br>* Other names: Atensine;|
| Active Comparator: Clonidine 3 mcg/Kg<br>General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 3 mcg/ Kg of clonidine for hypospadia surgery | Drug: Clonidine 3 mcg/ Kg<br>* Clonidine 3 mcg //Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery<br>* Other names: Atensine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption |  | 24 hours after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, Bupivacaine, Clonidine