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Comparison of safety and efficacy of propofol/fentanyl in pediatrics emergency department

Comparison of safety and efficacy of propofol/fentanyl and midazolam/fentanyl for procedural sedation

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250525065887N1
Enrollment
84
Registered
2025-05-28
Start date
2025-06-22
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Condition 1: Patients requiring LP. Condition 2: Patients requiring intubation. Condition 3: Patients with limb dislocation or fracture. Other reaction to spinal and lumbar puncture Respiratory disorder, unspecified Dislocation, sprain and strain of unspecified body region

Interventions

Intervention 1: Intervention group: In the first intervention group, intravenous fentanyl (1–2 micrograms per kilogram) will be administered first, followed by slow intravenous administration of propo

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Months to 18 Years

Inclusion criteria

Inclusion criteria: Children aged 3 months to 18 years who are referred to the emergency department of Mofid Children’s Hospital Patients who require procedural sedation

Exclusion criteria

Exclusion criteria: Patients with hemodynamic instability Patients with a history of cardiac diseases Children with known allergies to the study medications Children with allergies to eggs or soy Children classified as ASA physical status class 5 (high anesthesia risk)

Design outcomes

Primary

MeasureTime frame
Successful completion of the procedure. Timepoint: After the intervention. Method of measurement: "Success or failure of the procedure (which may include suturing, limb casting, lumbar puncture, intubation, etc.)".;Patient recovery time after sedation. Timepoint: After the intervention. Method of measurement: Measurement of the time interval between the administration of the last dose of sedative medication and the point at which the patient is deemed ready for discharge from the emergency department based on post-sedation discharge criteria.;Procedural distress. Timepoint: After the intervention. Method of measurement: To assess procedural distress in patients, the Observational Scale of Behavioral Distress (OSBD) will be used by an independent observer (a trained nurse from the emergency department). This scale is utilized to evaluate the level of behavioral distress in children under 18 years of age undergoing medical interventions.;Depth of sedation. Timepoint: After the intervention. Method of measurement: The Ramsay Sedation Scale will be used to assess the depth of sedation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKourosh Soltaniyeh Zanjani

Shahid Beheshti University of Medical Sciences

kouroshsoltaniye@gmail.com+98 21 2290 4603

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026