Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children

Study Overview
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Brief Summary
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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.

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 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

Official Title
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Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children: A Randomised Controlled Double Blind Study

Conditions
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Pain

Intervention / Treatment
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* Drug: Caudal Dexmedetomidine
* Drug: Intravenous dexmedetomidine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: caudal Dexmedetomidine<br>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<br>* Drug:Caudal bupivacaine 0.25% 1ml/kg Drug: Caudal dexmedetomidine 1µg/kg Intravenous: 10 ml normal saline sevoflurane Induction and maintenance of anesthesia<br>* Other names: Precedex;|
| Active Comparator: Intravenous Dexmedetomidine<br>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<br>* 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<br>* Other names: precedex;|
| Placebo Comparator: Placebo<br>Caudal: bupivacaine 0.25% 1ml/kg . Intravenous: 10 ml Normal saline Anesthesia was induced and maintained with sevoflurane | Drug: Placebo<br>* Drug:Caudal bupivacaine 0.25% 1ml/kg Intravenous: Normal saline 10 ml sevoflurane Induction and maintenance of anesthesia<br>* Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative behaviour scores | behaviour score was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals. | 2 hours | 
| Sevoflurane concentration | Sevoflurane concentration required to maintain Bispectral Index (BIS) monitor reading between 40 and 60 | 1 hour | 
| Blood pressure Perioperative blood pressure readings | Perioperative blood pressure readings | 2 hours | 
| Heart Rate | Perioperative heart rate readings | 2 hours | 
| the incidence of emergence agitation | Participants will be followed for the duration of PACU stay, an expected average of 2 hours | 2 hours | 
| Postoperative pain scores | postoperative pain score will be assessed over 24 hours | 24 hours | 
| Side effects | side effects including nausea, vomiting and urinary retention and lower limb weakness | 24 hours |