Clonidine and Morphine in Caudal Anesthesia

• ClinicalTrials.gov Identifier: NCT00672347
• Recruitment Status: Completed
• First Posted: May 6, 2008
• Last Update Posted: March 19, 2010
• Sponsor: Federal University of Minas Gerais
• Collaborator: Santa Casa de Misericórdia de Belo Horizonte
• Information provided by: Federal University of Minas Gerais

Study Description

Brief Summary:

Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better postoperative analgesia than either drug alone after urogenital pediatric surgery.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain	Drug: Clonidine; Drug: Morphine; Drug: Bupivacaine plus clonidine and morphine; Drug: Bupivacaine	Phase 1; Phase 2

Detailed Description:

It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, submitted to urogenital surgery, under general anesthesia and caudal block. The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine, bupivacaine plus morphine, bupivacaine plus clonidine and morphine. The peroperative consumption of analgesics and inhaled gases, BIS, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using Wong-Baker faces scale and pain and discomfort score scale, as well as the consumption of analgesics.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of Clonidine and Morphine Plus Bupivacaine in Caudal Peridural Anesthesia for Postoperative Analgesia After Pediatric Urogenital Surgery
• Study Start Date: July 2008
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: September 2009

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: B; compare caudal anesthesia with bupivacaine alone or in addition to morphine, clonidine or both	Drug: Bupivacaine; Caudal anesthesia with bupivacaine 0,166% 1 ml/kg
Active Comparator: C; compare caudal anesthesia with bupivacaine plus clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or morphine plus clonidine	Drug: Clonidine; 1 mcg/kg
Active Comparator: M; compare caudal anesthesia with bupivacaine plus morphine with caudal anesthesia with bupivacaine alone or in addition to clonidine or morphine plus clonidine	Drug: Morphine; 20 mcg/kg
Active Comparator: CM; compares caudal anesthesia with bupivacaine, morphine and clonidine with caudal anesthesia with bupivacaine alone or in addition to morphine or clonidine	Drug: Bupivacaine plus clonidine and morphine; bupivacaine 0,166% 1 ml/kg clonidine 1 mcg/kg morphine 20 mcg/kg

Outcome Measures

Primary Outcome Measures :

1. The overall postoperative consumption of analgesics. [ Time Frame: 24 hours ]

Secondary Outcome Measures :

1. The peroperative consumption of volatile anesthetics. [ Time Frame: 3 hours ]
2. The peroperative Bispectral Index measure. [ Time Frame: 3 hours ]
3. Postoperative Wong-Baker faces scale [ Time Frame: 24 hours ]
4. Postoperative pain and discomfort score scale [ Time Frame: 24 hours ]

Eligibility Criteria

• Ages Eligible for Study: 1 Year to 10 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Urogenital pediatric surgery
• Status physical(ASA) 1 and 2

Exclusion Criteria:

• Cutaneous infection in puncture site

Contacts and Locations

Locations

Brazil

Santa Casa de Belo Horizonte Hospital

Belo Horizonte, Minas Gerais, Brazil

Sponsors and Collaborators

Federal University of Minas Gerais

Santa Casa de Misericórdia de Belo Horizonte

Investigators

• Study Director: Renato S Gomez, PhD, MD; Federal University of Minas Gerais
• Principal Investigator: Magda L Fernandes, M; Federal University of Minas Gerais

More Information

Publications:

Tripi PA, Palmer JS, Thomas S, Elder JS. Clonidine increases duration of bupivacaine caudal analgesia for ureteroneocystostomy: a double-blind prospective trial. J Urol. 2005 Sep;174(3):1081-3.

Luz G, Innerhofer P, Oswald E, Salner E, Hager J, Sparr H. Comparison of clonidine 1 microgram kg-1 with morphine 30 micrograms kg-1 for post-operative caudal analgesia in children. Eur J Anaesthesiol. 1999 Jan;16(1):42-6.

Vetter TR, Carvallo D, Johnson JL, Mazurek MS, Presson RG Jr. A comparison of single-dose caudal clonidine, morphine, or hydromorphone combined with ropivacaine in pediatric patients undergoing ureteral reimplantation. Anesth Analg. 2007 Jun;104(6):1356-63, table of contents.

• Responsible Party: Renato Santiago Gomez - PhD,MD, Federal University of Minas Gerais
• ClinicalTrials.gov Identifier: NCT00672347 History of Changes
• Other Study ID Numbers: 210665
• First Posted: May 6, 2008
• Last Update Posted: March 19, 2010
• Last Verified: March 2010

Keywords provided by Federal University of Minas Gerais:

caudal anesthesia, clonidine, morphine, bupivacaine

Additional relevant MeSH terms:

Clonidine; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms; Morphine; Anesthetics; Bupivacaine; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Local; Sensory System Agents; Peripheral Nervous System Agents; Analgesics, Opioid; Narcotics; Analgesics; Antihypertensive Agents; Sympatholytics; Autonomic Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action