Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

This study has been completed.
Sponsor:
Collaborator:
West China Hospital
Information provided by (Responsible Party):
Yao Yusheng, Fujian Provincial Hospital
ClinicalTrials.gov Identifier:
NCT01701778
First received: October 2, 2012
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on caudal levobupivacaine analgesia in children undergoing lower abdominal surgeries.


Condition Intervention Phase
Inguinal Hernia
Cryptorchidism
Drug: Caudal Dexmedetomidine
Drug: Intravenous Dexmedetomidine
Drug: Placebo
Drug: sevoflurane
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Double-blind Randomized Controlled Trial of Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children

Resource links provided by NLM:


Further study details as provided by Fujian Provincial Hospital:

Primary Outcome Measures:
  • Time to first rescue medication [ Time Frame: From the administration of the caudal block to the first registration of a CHIPPS scores≥4,assessed up to 24h ] [ Designated as safety issue: No ]
    the Children and Infants Postoperative Pain Scale (CHIPPS)


Secondary Outcome Measures:
  • the number of patients not requiring rescue analgesia [ Time Frame: After surgery,up to 24h ] [ Designated as safety issue: No ]
    the quality of postoperative pain control

  • the sedation score [ Time Frame: After surgery, every 15min for the first 2 h, every 30min for the next 2h, hourly for the next 4h ] [ Designated as safety issue: No ]
    sedation was assessed using the Modified Ramsay Sedation Score

  • Residual motor block [ Time Frame: After awake,participants will be followed every 30min for the first 2h, hourly for the next 4h ] [ Designated as safety issue: No ]
    the degree of motor blockade was assessed using a modified Bromage scale

  • the incidence of emergence agitation [ Time Frame: Participants will be followed for the duration of PACU stay, an expected average of 2 hours ] [ Designated as safety issue: No ]
    The incidence of emergence agitation was evaluated by the Pediatric Anesthesia Emergence Delirium Scale(PAED)

  • side effects [ Time Frame: From the administration of the caudal block until the end of study period, assessed up to postoperative 24h ] [ Designated as safety issue: Yes ]
    side effects including bradycardia, hypotension, hypoxemia, nausea, vomiting and urinary retention

  • Pain intensity [ Time Frame: after surgery, 30min for first 4h, hourly for the next 4h and thereafter every 2h,assessed up to 24h ] [ Designated as safety issue: No ]
    Participants will be assessed with Children and Infants Postoperative Pain Scale (CHIPPS)


Estimated Enrollment: 90
Study Start Date: October 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caudal Dexmedetomidine

Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg

Intravenous: 10 ml normal saline

Anesthesia was induced and maintained with sevoflurane

Drug: Caudal Dexmedetomidine

Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg

Intravenous: 10 ml normal saline

Other Name: Precedex
Drug: sevoflurane
Induction and maintain anaesthesia
Other Name: sevoflurane
Experimental: Intravenous Dexmedetomidine

Caudal: Levobupivacaine 0.25% 1ml/kg

Intravenous: dexmedetomidine 1µg/kg

Anesthesia was induced and maintained with sevoflurane

Drug: Intravenous Dexmedetomidine

Caudal: Levobupivacaine 0.25% 1ml/kg

Intravenous: dexmedetomidine 1µg/kg

Other Name: Precedex
Drug: sevoflurane
Induction and maintain anaesthesia
Other Name: sevoflurane
Placebo Comparator: Placebo

Caudal: Levobupivacaine 0.25% 1ml/kg

Intravenous: 10 ml normal saline

Anesthesia was induced and maintained with sevoflurane

Drug: Placebo

Caudal: Levobupivacaine 0.25% 1ml/kg

Intravenous: 10 ml normal saline

Other Name: Levobupivacaine
Drug: sevoflurane
Induction and maintain anaesthesia
Other Name: sevoflurane

Detailed Description:

Single shot caudal epidural block is one of the most widespread technique for pediatric pain management after infraumbilical surgical procedures.However, in a significant proportion of patients, despite good initial analgesia from a caudal block with local anesthetic, pain develops after the block resolves.

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.

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA status I-II
  • aged 2-5 yr
  • Undergoing unilateral orchiopexy/inguinal hernia repair

Exclusion Criteria:

  • Hypersensitivity to any local anesthetics
  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01701778

Locations
China, Fujian
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350001
Sponsors and Collaborators
Yao Yusheng
West China Hospital
Investigators
Principal Investigator: Yusheng Yao, M.D. Fujian Provincial Hospital
Principal Investigator: Yanqing Chen, M.D. Fujian Provicial Hospital
Study Director: Jin Liu, M.D. West China Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Yao Yusheng, Double-blind randomized controlled trial of caudal versus intravenous dexmedetomidine for supplementation of caudal analgesia in children, Fujian Provincial Hospital
ClinicalTrials.gov Identifier: NCT01701778     History of Changes
Other Study ID Numbers: FujianPH, FujianPH-TRC-121002
Study First Received: October 2, 2012
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration
China: Ministry of Health

Keywords provided by Fujian Provincial Hospital:
Dexmedetomidine
Postoperative pain reaction
anesthesia
children

Additional relevant MeSH terms:
Hernia, Inguinal
Cryptorchidism
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical
Testicular Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases
Anesthetics
Sevoflurane
Levobupivacaine
Bupivacaine
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Anesthetics, General
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014