Caudal Bupivacaine vs Bupivacaine Plus Two Doses of Dexmedetomidine for Postoperative Analgesia in Children
- Conditions
- Pain, Postoperative
- Interventions
- Registration Number
- NCT02385435
- Lead Sponsor
- 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 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
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dexmedetomidine 1μg.kg-1 dexmedetomidine 1μg.kg-1 Single shot Caudal dexmedetomidine 1μg.kg-1 used as the second arm intervention dexmedetomidine 2μg.kg-1 dexmedetomidine 2μg.kg-1 Single shot Caudal dexmedetomidine 2 μg.kg-1 used as the second arm intervention Bupivacaine Bupivacaine single shot caudal plain bupivacaine at a dose of 2mg/kg is used as a reference control drug.
- Primary Outcome Measures
Name Time Method Number of postoperative analgesia doses 24 hours Number of paracetamol doses needed by each patient
Time to first analgesic requirement 24 hours The time from end of surgery to the first requirement of postoperative analgesia
Postoperative pain scores 24 hours
- Secondary Outcome Measures
Name Time Method Sevoflurane concentration intraoperative Sevoflurane concentration required to maintain Bispectral Index (BIS) monitor reading between 40 and 60%.
Postoperative sedation scores 2 hours Level of sedation was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals.
Blood pressure intraoperative Intraoperative blood pressure readings
Heart Rate intraoperative Intraoperative heart rate readings
Side effects of study drugs 24 hours Any side effects of study drugs in the first 24 hours postoperative hours were recorded (nausea, Vomiting, urine retention, lower limb weakness and emesis).