Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children
1 other identifier
interventional
75
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 pain
Started Jan 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 12, 2015
CompletedFirst Posted
Study publicly available on registry
April 14, 2015
CompletedApril 14, 2015
April 1, 2015
9 months
March 12, 2015
April 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Time to first analgesic requirement
Time to first rescue medication. The time from end of surgery to the first requirement of postoperative analgesia,pain score ≥4
24 hours
Secondary Outcomes (7)
Postoperative behaviour scores
2 hours
Sevoflurane concentration
1 hour
Blood pressure Perioperative blood pressure readings
2 hours
Heart Rate
2 hours
the incidence of emergence agitation
2 hours
- +2 more secondary outcomes
Study Arms (3)
caudal Dexmedetomidine
ACTIVE COMPARATORDrug:Caudal Bupivacaine 0.25% 1ml/kg . Drug:caudal Dexmedetomidine 1μg /kg. Intravenous :10 ml normal saline Anesthesia was induced and maintained with sevoflurane
Intravenous Dexmedetomidine
ACTIVE COMPARATORDrug: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
Placebo
PLACEBO COMPARATORCaudal: bupivacaine 0.25% 1ml/kg . Intravenous: 10 ml Normal saline Anesthesia was induced and maintained with sevoflurane
Interventions
Drug:Caudal bupivacaine 0.25% 1ml/kg Drug: Caudal dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline sevoflurane Induction and maintenance of anesthesia
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
Drug:Caudal bupivacaine 0.25% 1ml/kg Intravenous: Normal saline 10 ml sevoflurane Induction and maintenance of anesthesia
Eligibility Criteria
You may qualify if:
- Patients with American Society of Anesthesiologists (ASA) - I
- Scheduled for lower abdominal and perineal surgery
- Under general anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (7)
Zhang C, Hu J, Liu X, Yan J. Effects of intravenous dexmedetomidine on emergence agitation in children under sevoflurane anesthesia: a meta-analysis of randomized controlled trials. PLoS One. 2014 Jun 16;9(6):e99718. doi: 10.1371/journal.pone.0099718. eCollection 2014.
PMID: 24932765BACKGROUNDGuler G, Akin A, Tosun Z, Ors S, Esmaoglu A, Boyaci A. Single-dose dexmedetomidine reduces agitation and provides smooth extubation after pediatric adenotonsillectomy. Paediatr Anaesth. 2005 Sep;15(9):762-6. doi: 10.1111/j.1460-9592.2004.01541.x.
PMID: 16101707BACKGROUNDAl-Zaben KR, Qudaisat IY, Al-Ghanem SM, Massad IM, Al-Mustafa MM, Al-Oweidi AS, Abu-Halaweh SA, Abu-Ali HM, Saleem MM. Intraoperative administration of dexmedetomidine reduces the analgesic requirements for children undergoing hypospadius surgery. Eur J Anaesthesiol. 2010 Mar;27(3):247-52. doi: 10.1097/EJA.0b013e32833522bf.
PMID: 19952754BACKGROUNDKim NY, Kim SY, Yoon HJ, Kil HK. Effect of dexmedetomidine on sevoflurane requirements and emergence agitation in children undergoing ambulatory surgery. Yonsei Med J. 2014 Jan;55(1):209-15. doi: 10.3349/ymj.2014.55.1.209.
PMID: 24339309BACKGROUNDShe YJ, Xie GT, Tan YH, Kuang XH, Yu GF, Lian GH, Song XR. A prospective study comparing the onset and analgesic efficacy of different concentrations of levobupivacaine with/without dexmedetomidine in young children undergoing caudal blockade. J Clin Anesth. 2015 Feb;27(1):17-22. doi: 10.1016/j.jclinane.2014.09.005. Epub 2014 Nov 21.
PMID: 25468576BACKGROUNDSchnabel A, Reichl SU, Poepping DM, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of intraoperative dexmedetomidine for acute postoperative pain in children: a meta-analysis of randomized controlled trials. Paediatr Anaesth. 2013 Feb;23(2):170-9. doi: 10.1111/pan.12030. Epub 2012 Oct 9.
PMID: 23043461BACKGROUNDFares KM, Othman AH, Alieldin NH. Efficacy and safety of dexmedetomidine added to caudal bupivacaine in pediatric major abdominal cancer surgery. Pain Physician. 2014 Sep-Oct;17(5):393-400.
PMID: 25247897BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
khaled R Al-zaben
University of Jordan
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
March 12, 2015
First Posted
April 14, 2015
Study Start
January 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
April 14, 2015
Record last verified: 2015-04