a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients

Phase 3

Recruiting

• Conditions: Perioperative/Postoperative Complications; Anxiety State
• Interventions: Other: Placebo; Drug: Midazolam; Drug: Dexmedetomidine

• Registration Number: NCT04356638
• Lead Sponsor: King Faisal Specialist Hospital & Research Center

Brief Summary

This research study to evaluate the relative efficacy of Dexmedetomidine, Midazolam, and compare them to the current KFSH\&RC standard of care. Compare the safety and the frequency of adverse effects of treatment arms.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-22
• Study Start: 2021-10-17
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• All pediatric outpatients coming for MRI investigations requiring general anesthesia at King Faisal Specialist Hospital & Research Center (KFSH&RC) age 1-12 years

Exclusion Criteria

• Weight ≥ 40 kilograms
• Allergies to the study drug
• Refused to take the study drug
• Severe learning disability
• Patient on Digoxin medication
• Patient on beta-blocker medication
• Cardiac disease with abnormal conduction system
• Nasal anatomical abnormality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
The sedative pre-medication oral Midazolam	Midazolam	-
The sedative pre-medication intranasal Dexmedetomidine	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Safety - Hemodynamic stability	30 Minutes	The systolic and diastolic blood pressures will be measured when the subject enters the recovery room, and then each ten minutes until the subject goes into the MRI suite and general anesthesia is induced.
Safety - Respiratory function	30 Minutes	The respiratory rate will be measured when the subject enters the recovery room, and then each ten minutes until the subject goes into the MRI suite and general anesthesia is induced.
Anxiety Level	30 Minutes	Comparison of the level of anxiety as measured by The Modified Yale Preoperative Anxiety Scale - Short Form (mYPAS-SF) at the time when the child checks in at the front desk (say mYPAS-SF1), with when the attempt will be made to insert an IV line (say mYPAS-SF2). This scale is a score ranging from four (little anxiety) to twenty two (much anxiety).
Oxygen saturation	30 Minutes	The SpO2 will be measured when the subject enters the recovery room, and then each ten minutes until the subject goes into the MRI suite and general anesthesia is induced.

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale for child anxiety	10 Minutes	The VAS will be measured when the subject enters the recovery room and when IV cannulation is performed
IV cannulation procedure completion and number of attempts - yes or no	10 Minutes	This will be measured when the IV cannulation procedure is successful or not
Assessment of the Pediatric Anesthesia Emergence Delirium (PAED-scale) for the subjects	60 Minutes	This measurement will assess the emergence delirium of the participants when they have completed the MRI under general anesthesia - every 10 minutes until discharge from recovery room
Post Hospitalization Behavior Questionnaire for Ambulatory Surgery	Day 2 post procedure	A two day post assessment will be completed by interviewing the parents about changes in behavior derived from the questionnaire
Likert scale assessment of how cooperative/easy to handle the child	10 Minutes	This will be measured when the IV cannulation is completed

Trial Locations

Locations (1)

King Faisal Specialist Hospital & Research Center; 🇸🇦 Riyadh, Saudi Arabia