Caudal Bupivacaine vs Bupivacaine Plus Two Doses of Dexmedetomidine for Postoperative 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 two doses of dexmedetomidine (1 and 2 µg.kg-1) co-administered with bupivacaine with bupivacaine alone for caudal analgesia in children undergoing infra-umbilical surgery.

Detailed Description
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Quality assurance plan for data validation and registry: After Data was registered, it was reviewed by a second person who compared it to the Data in patient data collection forms. Data check: carried out using Statistical Package for the Social Sciences (SPSS) variable definition protocols. Also data were entered in EXCEL sheets for comparisons to guarantee consistency. Source data verification: Paper case report forms and medical records. Standard Operating Procedures to address registry operations and analysis activities: Eligible patients were recruited after obtaining consent. Data was collected by qualified personnel rained on the process. Data was entered into Excel sheets and SPSS programs and compared for consistency. Analysis of Data was carried out by a qualified statistician. Adverse events were reported as yes/no variables. Data of patients who had Change in management was omitted from analysis. Sample size assessment: Sample size was calculated to detect a 65% reduction in the analgesic requirement during the first 24 h from 75% in the bupivacaine group with α= 0.05 and β=0.80. Plan for missing data: Patients with missing Data were omitted from statistical analysis. Statistical analysis plan: carried out using International Business Machines (IBM) statistics 19.0 statistical package for windows. Data were compared using analysis of variance for continuous variables, Kruskal-Wallis test for ordinal, and chi square test for categorical ones. Post hoc analyses were carried out as appropriate.

Official Title
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Comparison of Caudal Bupivacaine Alone With Bupivacaine Plus Two Doses of Dexmedetomidine for Postoperative Analgesia in Pediatric Patients Undergoing Infra-umbilical Surgery: A Randomized Controlled Double Blinded Study

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: dexmedetomidine 1μg.kg-1
* Drug: dexmedetomidine 2μg.kg-1


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: history of developmental delay or mental retardation known or suspected coagulopathy or recent use of anticoagulant/antiplatelet drugs. known allergy to any of the study drugs. any signs of infection or congenital abnormalities at the site of the proposed caudal 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: Bupivacaine<br>single shot caudal plain bupivacaine at a dose of 2mg/kg is used as a reference control drug. | Drug: Bupivacaine<br>* Caudal Bupivacaine 2 mg/kg single shot<br>* Other names: Broup B;|
| Active Comparator: dexmedetomidine 1μg.kg-1<br>Single shot Caudal dexmedetomidine 1μg.kg-1 used as the second arm intervention | Drug: dexmedetomidine 1μg.kg-1<br>* Caudal dexmedetomidine 1μg.kg-1, single shot<br>* Other names: Group BD1;|
| Active Comparator: dexmedetomidine 2μg.kg-1<br>Single shot Caudal dexmedetomidine 2 μg.kg-1 used as the second arm intervention | Drug: dexmedetomidine 2μg.kg-1<br>* Caudal dexmedetomidine 2μg.kg-1, single shot<br>* Other names: Group BD2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first analgesic requirement | The time from end of surgery to the first requirement of postoperative analgesia | 24 hours | 
| Postoperative pain scores |  | 24 hours | 
| Number of postoperative analgesia doses | Number of paracetamol doses needed by each patient | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative sedation scores | Level of sedation 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%. | intraoperative | 
| Blood pressure | Intraoperative blood pressure readings | intraoperative | 
| Heart Rate | Intraoperative heart rate readings | intraoperative | 
| Side effects of study drugs | Any side effects of study drugs in the first 24 hours postoperative hours were recorded (nausea, Vomiting, urine retention, lower limb weakness and emesis). | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caudal block