Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children
NCT ID: NCT01701778
Last Updated: 2018-11-15
Study Results
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Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2012-10-31
2014-01-31
Brief Summary
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Detailed Description
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Dexmedetomidine is used increasingly in pediatric anesthesia practice to prolong the duration of action of caudal block with a local anesthetic agent.But which route of administration of clonidine is the most beneficial remains unknown.
The investigators performed prospective randomized double-blind study to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on postoperative analgesia after caudal levobupivacaine for inguinal herniorrhaphy or orchidopexy surgery.
90 children (ASAⅠorⅡ,aged 2-5 yr) undergoing unilateral orchiopexy or inguinal herniorrhaphy were included in this study. Anesthesia was induced with sevoflurane via a facemask, followed by placement of a laryngeal mask airway. Anesthesia was maintained with sevoflurane 2-3% in oxygen-air.Then,caudal block was applied. Patients were randomly assigned in three groups. Group Cau-DEX (n = 30): Caudal Levobupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml normal saline i.v.;Group IV-DEX(n = 30): Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg(10 ml)i.v.;Group Placebo(n = 30): Levobupivacaine 0.25% and 10 ml normal saline intravenous.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Caudal Dexmedetomidine
Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg
Intravenous: 10 ml normal saline
Anesthesia was induced and maintained with sevoflurane
Caudal Dexmedetomidine
Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg
Intravenous: 10 ml normal saline
sevoflurane
Induction and maintain anaesthesia
Intravenous Dexmedetomidine
Caudal: Levobupivacaine 0.25% 1ml/kg
Intravenous: dexmedetomidine 1µg/kg
Anesthesia was induced and maintained with sevoflurane
Intravenous Dexmedetomidine
Caudal: Levobupivacaine 0.25% 1ml/kg
Intravenous: dexmedetomidine 1µg/kg
sevoflurane
Induction and maintain anaesthesia
Placebo
Caudal: Levobupivacaine 0.25% 1ml/kg
Intravenous: 10 ml normal saline
Anesthesia was induced and maintained with sevoflurane
Placebo
Caudal: Levobupivacaine 0.25% 1ml/kg
Intravenous: 10 ml normal saline
sevoflurane
Induction and maintain anaesthesia
Interventions
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Caudal Dexmedetomidine
Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg
Intravenous: 10 ml normal saline
Intravenous Dexmedetomidine
Caudal: Levobupivacaine 0.25% 1ml/kg
Intravenous: dexmedetomidine 1µg/kg
Placebo
Caudal: Levobupivacaine 0.25% 1ml/kg
Intravenous: 10 ml normal saline
sevoflurane
Induction and maintain anaesthesia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aged 2-5 yr
* Undergoing unilateral orchiopexy/inguinal hernia repair
Exclusion Criteria
* Patient has history of allergy, intolerance, or reaction to dexmedetomidine
* Infections at puncture sites
* Bleeding diathesis
* Preexisting neurological disease
* Diabetes mellitus
* Children with uncorrected cardiac lesions
* Children with heart block or liver impairment
2 Years
5 Years
MALE
No
Sponsors
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West China Hospital
OTHER
Yao Yusheng
OTHER
Responsible Party
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Yao Yusheng
Double-blind randomized controlled trial of caudal versus intravenous dexmedetomidine for supplementation of caudal analgesia in children
Principal Investigators
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Yusheng Yao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fujian Provincial Hospital
Yanqing Chen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fujian Provicial Hospital
Jin Liu, M.D.
Role: STUDY_DIRECTOR
West China Hospital
Locations
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Fujian Provincial Hospital
Fuzhou, Fujian, China
Countries
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References
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Yao Y, Yu C, Zhang X, Guo Y, Zheng X. Caudal and intravenous dexmedetomidine similarly prolong the duration of caudal analgesia in children: A randomized controlled trial. Paediatr Anaesth. 2018 Oct;28(10):888-896. doi: 10.1111/pan.13469.
Related Links
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Effect of dexmedetomidine on the characteristics of bupivacaine in a caudal block in pediatrics
Other Identifiers
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FujianPH-TRC-121002
Identifier Type: REGISTRY
Identifier Source: secondary_id
FujianPH
Identifier Type: -
Identifier Source: org_study_id
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