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Completed

NCT Number: NCT00672347

Clonidine and Morphine in Caudal Anesthesia

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Santa Casa de Belo Horizonte Hospital

Belo Horizonte, Minas Gerais, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Cutaneous infection in puncture site

Treatment and study plan

Clonidine

Drug

1 mcg/kg

Morphine

Drug

20 mcg/kg

Bupivacaine plus clonidine and morphine

Drug

bupivacaine 0,166% 1 ml/kg

clonidine 1 mcg/kg

morphine 20 mcg/kg

Bupivacaine

Drug

Caudal anesthesia with bupivacaine 0,166% 1 ml/kg

Primary outcomes

  1. The overall postoperative consumption of analgesics.

    Time frame: 24 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Collaborators

  • Santa Casa de Misericórdia de Belo Horizonte

Registry information

Official study title

Comparison of Clonidine and Morphine Plus Bupivacaine in Caudal Peridural Anesthesia for Postoperative Analgesia After Pediatric Urogenital Surgery

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
May 6, 2008
Registry last updated
Mar 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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