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

NCT02769390 | Completed Phase 2 DMC

• 1 other identifier: CAAE23332313600005149
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Keywords

Analgesia; Bupivacaine; Clonidine

Outcome Measures

Primary Outcomes (1)

• Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption

  24 hours after the surgery

Study Arms (4)

Bupivacaine 0,166%

NO INTERVENTION

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

Clonidine 1 mcg/Kg

ACTIVE COMPARATOR

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

Drug: Clonidine 1 mcg/Kg

Clonidine 2 mcg/ Kg

ACTIVE COMPARATOR

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

Drug: Clonidine 2 mcg/ Kg

Clonidine 3 mcg/Kg

ACTIVE COMPARATOR

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

Drug: Clonidine 3 mcg/ Kg

Interventions

Clonidine 1 mcg/Kg DRUG

Clonidine 1 mcg/Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery

Also known as: Atensine

Clonidine 1 mcg/Kg

Clonidine 2 mcg/ Kg DRUG

Clonidine 2 mcg//Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery

Also known as: Atensine

Clonidine 2 mcg/ Kg

Clonidine 3 mcg/ Kg DRUG

Clonidine 3 mcg //Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery

Also known as: Atensine

Clonidine 3 mcg/Kg

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• CHildren 1 - 10 years old.
• ASA I E II ( American Society of Anesthesiology)
• hypospadias surgery

You may not qualify if:

• parents refuse
• Infection
• Coagulation disorders
• Allergy to anesthetics
• Abnormalities of the sacral spine

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Related Publications (2)

• 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.

  PMID: 22159880 BACKGROUND

• 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.

  PMID: 22855315 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Clonidine; Diazepam

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• ana claudia mota bonisson, M

  Hospital da Baleia - Fundação Benjamim Guimaraes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: May 11, 2016
• Study Start: July 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 13, 2016

Record last verified: 2016-05