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Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children

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ClinicalTrials.gov Identifier: NCT02416063
Recruitment Status : Completed
First Posted : April 14, 2015
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Khaled Radian Al-zaben, University of Jordan

Brief Summary:
The aim of this prospective randomized double-blind study was to compare the analgesic efficacy and the side effects of dexmedetomidine (1 µg.kg-1) co-administered with bupivacaine for caudal analgesia or intravenously in children undergoing infra-umbilical surgery.

Condition or disease Intervention/treatment Phase
Pain Drug: Caudal Dexmedetomidine Drug: Intravenous dexmedetomidine Drug: Placebo Phase 2

Detailed Description:

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 dexmedetomidine 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 bupivacaine in children undergoing infra-umbilical surgery.

75 children (ASAⅠorⅡ,aged 1-6 yr) undergoing infra-umbilical surgery 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 B-Dcau (n = 25): Caudal bupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml normal saline i.v.;Group B-Div (n = 25): bupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg(10 ml)i.v.;Group B(n = 25): bupivacaine 0.25% and 10 ml normal saline intravenous


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children: A Randomised Controlled Double Blind Study
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: caudal Dexmedetomidine

Drug:Caudal Bupivacaine 0.25% 1ml/kg .

Drug:caudal Dexmedetomidine 1μg /kg.

Intravenous :10 ml normal saline

Anesthesia was induced and maintained with sevoflurane

Drug: Caudal Dexmedetomidine

Drug:Caudal bupivacaine 0.25% 1ml/kg

Drug: Caudal dexmedetomidine 1µg/kg

Intravenous: 10 ml normal saline

sevoflurane Induction and maintenance of anesthesia

Other Names:
  • dexmedetomidine
  • Precedex

Active Comparator: Intravenous Dexmedetomidine

Drug:Caudal bupivacaine 0.25% 1ml/kg

Drug: Intravenous dexmedetomidine 1µg/kg in a 10 ml volume normal saline

Anesthesia was induced and maintained with sevoflurane

Drug: Intravenous dexmedetomidine

Drug:Caudal bupivacaine 0.25% 1ml/kg.

Drug:Intravenous dexmedetomidine1 μg /kg in a total volume of 10 ml

sevoflurane Induction and maintenance of anesthesia

Other Name: precedex

Placebo Comparator: Placebo

Caudal: bupivacaine 0.25% 1ml/kg .

Intravenous: 10 ml Normal saline

Anesthesia was induced and maintained with sevoflurane

Drug: Placebo

Drug:Caudal bupivacaine 0.25% 1ml/kg

Intravenous: Normal saline 10 ml

sevoflurane Induction and maintenance of anesthesia

Other Name: normal saline




Primary Outcome Measures :
  1. Time to first analgesic requirement [ Time Frame: 24 hours ]
    Time to first rescue medication. The time from end of surgery to the first requirement of postoperative analgesia,pain score ≥4


Secondary Outcome Measures :
  1. Postoperative behaviour scores [ Time Frame: 2 hours ]
    behaviour score was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals.

  2. Sevoflurane concentration [ Time Frame: 1 hour ]
    Sevoflurane concentration required to maintain Bispectral Index (BIS) monitor reading between 40 and 60

  3. Blood pressure Perioperative blood pressure readings [ Time Frame: 2 hours ]
    Perioperative blood pressure readings

  4. Heart Rate [ Time Frame: 2 hours ]
    Perioperative heart rate readings

  5. the incidence of emergence agitation [ Time Frame: 2 hours ]
    Participants will be followed for the duration of PACU stay, an expected average of 2 hours

  6. Postoperative pain scores [ Time Frame: 24 hours ]
    postoperative pain score will be assessed over 24 hours

  7. Side effects [ Time Frame: 24 hours ]
    side effects including nausea, vomiting and urinary retention and lower limb weakness



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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with American Society of Anesthesiologists (ASA) - I
  • Scheduled for lower abdominal and perineal surgery
  • Under general anesthesia

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
  • Children with uncorrected cardiac lesions
  • Children with heart block

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416063


Sponsors and Collaborators
University of Jordan
Investigators
Principal Investigator: khaled R Al-zaben University of Jordan

Publications:

Responsible Party: Khaled Radian Al-zaben, Dr, University of Jordan
ClinicalTrials.gov Identifier: NCT02416063     History of Changes
Other Study ID Numbers: Faculty of medicine-JU
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Sevoflurane
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General