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

Perioperative/Postoperative Complications Clinical Trial

Official title:

A Partially Double-Blinded, Randomized, Controlled, Placebo-Controlled Study, a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04356638
• Other study ID #: 2191310
• Status: Recruiting
• Phase: Phase 3
• Start date: October 17, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2023
• Source: King Faisal Specialist Hospital & Research Center
• Contact: Lars Engborg, MD
• Phone: +966555327987
• Email: lengborg[@]kfshrc.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety State
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Drug:
• Midazolam
Oral Midazolam and intranasal placebo
• Dexmedetomidine
Intranasal Dexmedetomidine and oral placebo

Other:
• Placebo
Placebo orally and intranasally

Locations

Country	Name	City	State
Saudi Arabia	King Faisal Specialist Hospital & Research Center	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Faisal Specialist Hospital & Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety Level	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).	30 Minutes
Primary	Safety - Hemodynamic stability	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.	30 Minutes
Primary	Safety - Respiratory function	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.	30 Minutes
Primary	Oxygen saturation	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.	30 Minutes
Secondary	Visual Analog Scale for child anxiety	The VAS will be measured when the subject enters the recovery room and when IV cannulation is performed	10 Minutes
Secondary	IV cannulation procedure completion and number of attempts - yes or no	This will be measured when the IV cannulation procedure is successful or not	10 Minutes
Secondary	Likert scale assessment of how cooperative/easy to handle the child	This will be measured when the IV cannulation is completed	10 Minutes
Secondary	Assessment of the Pediatric Anesthesia Emergence Delirium (PAED-scale) for the subjects	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	60 Minutes
Secondary	Post Hospitalization Behavior Questionnaire for Ambulatory Surgery	A two day post assessment will be completed by interviewing the parents about changes in behavior derived from the questionnaire	Day 2 post procedure