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

Postoperative Pain Clinical Trial

— clonidine  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769390
• Other study ID #: CAAE23332313600005149
• Status: Completed
• Phase: Phase 2
• First received: April 9, 2015
• Last updated: May 12, 2016
• Start date: July 2015
• Est. completion date: November 2015

Study information

• Verified date: May 2016
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypospadias
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Clonidine 1 mcg/Kg
Clonidine 1 mcg/Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
• Clonidine 2 mcg/ Kg
Clonidine 2 mcg//Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
• Clonidine 3 mcg/ Kg
Clonidine 3 mcg //Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

References & Publications (2)

Fernandes ML, Pires KC, Tibúrcio 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. — View 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. Review. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption		24 hours after the surgery	Yes