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

This study is designed to compare the safety and efficacy of propofol/fentanyl versus midazolam/fentanyl combinations for procedural sedation in the emergency department of Mofid Children’s Hospital.

This is a randomized, single-blind, parallel-group, phase II clinical trial without a control group, involving 84 patients. Randomization will be carried out using stratified block randomization.

This is a randomized, single-blind clinical trial designed to compare the safety and efficacy of two drug combinations (propofol/fentanyl and midazolam/fentanyl) for procedural sedation in the emergency department of Mofid Children’s Hospital. Single-blinding means that participants (children and their parents) will be unaware of the drug combination being administered.

The study population will include all children aged 3 months to 18 years who are referred to the emergency department of Mofid Children’s Hospital and require procedural sedation. Children with hemodynamic instability, a history of cardiac diseases, known allergies to the study drugs, sensitivity to eggs or soy, and those classified as ASA physical status 5 (high anesthesia risk) will be excluded from the study.

Patients will be randomly assigned to one of two groups: propofol/fentanyl or midazolam/fentanyl. In the propofol/fentanyl group, due to the onset time of the medications, intravenous fentanyl (1–2 µg/kg) will be administered first, followed by slow intravenous injection of propofol (1–2 mg/kg). In the midazolam/fentanyl group, intravenous midazolam (0.05–0.1 mg/kg) will be administered first, followed by slow intravenous injection of fentanyl (1–2 µg/kg).

1- Successful completion of the procedure 2- Recovery time 3- Procedural distress 4- Depth of sedation

The randomization method used in this study will be stratified block randomization. Patients will be stratified based on key characteristics such as age, gender, and ASA, and then randomly assigned to study groups using a block size of 4, generated by random allocation software. The random sequence will be created using a random number generator within the software, and the allocation list will be prepared in advance by an independent person not involved in the study implementation or outcome assessment. For allocation concealment, sealed, opaque, and sequentially numbered envelopes will be used. These envelopes will be opened only by the person enrolling the patient, right at the point of assignment.

This study will be a single-blind trial. In this context, single-blinding means that the participants (patients and their parents) will not be aware of the specific drug combination administered (either propofol/fentanyl or midazolam/fentanyl). Due to the visible differences between the drugs and the necessity of ensuring medication safety, the administering physician will be aware of the drug type. However, the responsibility for evaluating outcome variables such as pain, distress, depth of sedation, and documentation of adverse events will lie with an independent observer (a trained nurse) who will be blinded to the group allocation.

All demographic and clinical data collected from patients in the present study will be shared after de-identification.

Access to the data will begin following the publication of the study results in the form of a scientific article.

The data will be openly accessible to the public.

Data aggregation for multicenter studies will be possible upon request to the clinical trial coordinator (Dr. Kourosh Soltaniyeh Zanjani) and approval by the research team.

To access the study data, please contact the clinical trial coordinator, Dr. Kourosh Soltaniyeh Zanjani, via email at kouroshsoltaniye@gmail.com.

Any requests regarding the research or industrial use of the data will be reviewed by the clinical trial coordinator and the research team and will be answered within seven working days.