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

Federal University of Minas Gerais

Status and phase: Completed; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: Clonidine 2 mcg/ Kg; Drug: Clonidine 1 mcg/Kg; Drug: Clonidine 3 mcg/ Kg

Study type: Interventional

Funder types: Other

Identifiers

NCT02769390

CAAE23332313600005149

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: Male

Ages: 1 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups

Bupivacaine 0,166%

No Intervention group

Description:

General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% for hypospadia surgery

Clonidine 1 mcg/Kg

Active Comparator group

Description:

IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 1 mcg/ Kg of clonidine for hypospadia surgery

Treatment:

Drug: Clonidine 1 mcg/Kg

Clonidine 2 mcg/ Kg

Active Comparator group

Description:

IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 2 mcg/ Kg of clonidine for hypospadia surgery

Treatment:

Drug: Clonidine 2 mcg/ Kg

Clonidine 3 mcg/Kg

Active Comparator group

Description:

General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 3 mcg/ Kg of clonidine for hypospadia surgery

Treatment:

Drug: Clonidine 3 mcg/ Kg