Pain, Postoperative
Conditions
Keywords
caudal block
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.
Interventions
DRUGBupivacaine
Caudal Bupivacaine 2 mg/kg single shot
DRUGdexmedetomidine 1μg.kg-1
Caudal dexmedetomidine 1μg.kg-1, single shot
DRUGdexmedetomidine 2μg.kg-1
Caudal dexmedetomidine 2μg.kg-1, single shot
Sponsors
University of Jordan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Number of postoperative analgesia doses | 24 hours | Number of paracetamol doses needed by each patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sevoflurane concentration | intraoperative | Sevoflurane concentration required to maintain Bispectral Index (BIS) monitor reading between 40 and 60%. |
| Heart Rate | intraoperative | Intraoperative heart rate readings |
| Blood pressure | intraoperative | Intraoperative blood pressure 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). |
| Postoperative sedation scores | 2 hours | Level of sedation was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals. |
Outcome results
None listed