Efficacy of Fentanyl and Midazolam versus Ketamine and Midazolam before invasive procedures in children with cancer

Efficacy of Fentanyl and Midazolam compare with Ketamine and Midazolam in analgesic effect and nausea/vomiting after lumbar puncture and/or bone marrow examination in children with cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20200807001

Enrollment

Unknown

Registered

2020-08-07

Start date

2018-08-15

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric oncology patients who required intravenous sedative medication before performing invasive procedures (lumbar puncture and bone marrow procedure). Pediatric oncology Invasive procedures Nonanesthesiologists Fentanyl Midazolam Ketamine

Interventions

Patients were randomly assigned in a double&#45

blinded fashion to receive intravenous fentanyl and midazolam at 1 mcg/kg/dose and 0.1 mg/kg/dose&#44

respectively.,Patients were randomly assigned in a double&#45

blinded fashion to receive intravenous ketamine and midazolam at 1 mg/kg/dose and 0.1 mg/kg/dose&#44

respectively.

Experimental Drug,Experimental Drug

Fentanyl and Midazolam ,Ketamine and Midazolam

Eligibility

Sex/Gender

All

Age

No minimum to 20 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Efficacy of Fentanyl and Midazolam versus Ketamine and Midazolam before invasive procedures 2 years Independent sample t-test with p-value < 0.05	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Thailand

Contacts

Public ContactChalinee Monsereenusorn

Phramongkutklao Hospital and College of Medicine

chalinee_monsereenusorn@pedpmk.org+66816415600

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026