ClinicalTrials.Veeva

Menu

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

F

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

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems