Clinical trial NCT02769390: Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery
Official title: Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Keywords: Analgesia
Bupivacaine
Clonidine
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 80
Sex: MALE
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption
timeFrame: 24 hours after the surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital da Baleia - Fundação Benjamim Guimaraes
name: ana claudia mota bonisson, M
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandes ML, Pires KC, Tiburcio MA, Gomez RS. Caudal bupivacaine supplemented with morphine or clonidine, or supplemented with morphine plus clonidine in children undergoing infra-umbilical urological and genital procedures: a prospective, randomized and double-blind study. J Anesth. 2012 Apr;26(2):213-8. doi: 10.1007/s00540-011-1297-y. Epub 2011 Dec 10.
citation: Mauch J, Weiss M. [Pediatric caudal anesthesia: importance and aspects of safety concerns]. Schmerz. 2012 Aug;26(4):443-53; quiz 454. doi: 10.1007/s00482-012-1202-0. German.