Efficacy of Fentanyl and Midazolam versus Ketamine and Midazolam before invasive procedures in children with cancer
Phase 3
Completed
- Conditions
- Pediatric oncology patients who required intravenous sedative medication before performing invasive procedures (lumbar puncture and bone marrow procedure).Pediatric oncologyInvasive proceduresNonanesthesiologistsFentanylMidazolamKetamine
- Registration Number
- TCTR20200807001
- Lead Sponsor
- Office of Research and Development, Phramongkutklao Hospital and College of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria
All children between 1 and 20 years with cancers who required intravenous sedative medication and invasive procedure (bone marrow procedure and/or lumbar puncture) between August 1, 2018 and July 31, 2020.
Exclusion Criteria
Patients who received antiemetic drugs or had nausea/vomiting or pain within 24 hours of the treatment, with a known allergy to fentanyl or ketamine or midazolam, contraindications for fentanyl or ketamine or midazolam such as increased intracranial pressure, respiratory
compromise, vascular aneurysm, or major psychiatric problem.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of Fentanyl and Midazolam versus Ketamine and Midazolam before invasive procedures 2 years Independent sample t-test with p-value < 0.05
- Secondary Outcome Measures
Name Time Method Satisfaction score of Fentanyl and Midazolam versus Ketamine and Midazolam before invasive procedure 2 years Wilcoxon signed rank test with p-value < 0.05,Pain score of Fentanyl and Midazolam versus Ketamine and Midazolam before invasive procedure 2 years Wilcoxon signed rank test with p-value < 0.05,The frequency of nausea vomiting score of Fentanyl and Midazolam versus Ketamine and Midazolam 2 years Wilcoxon signed rank test and paired sample t-test with p-value < 0.05,Other side effects of Fentanyl and Midazolam versus Ketamine and Midazolam before invasive procedure 2 years Descriptive statistics and chi-squared test with p-value < 0.05