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

NCT04356638 | Unknown Phase 3

• 1 other identifier: 2191310
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety State; Perioperative/Postoperative Complications

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• Visual Analog Scale for child anxiety

  10 Minutes

• IV cannulation procedure completion and number of attempts - yes or no

  10 Minutes

• Likert scale assessment of how cooperative/easy to handle the child

  10 Minutes

• Assessment of the Pediatric Anesthesia Emergence Delirium (PAED-scale) for the subjects

  60 Minutes

• Post Hospitalization Behavior Questionnaire for Ambulatory Surgery

  Day 2 post procedure

Study Arms (4)

The sedative pre-medication oral Midazolam

ACTIVE COMPARATOR

Drug: Midazolam

The sedative pre-medication intranasal Dexmedetomidine

ACTIVE COMPARATOR

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

Other: Placebo

No Sedative Pre-medication

NO INTERVENTION

Interventions

Midazolam DRUG

Oral Midazolam and intranasal placebo

The sedative pre-medication oral Midazolam

Dexmedetomidine DRUG

Intranasal Dexmedetomidine and oral placebo

The sedative pre-medication intranasal Dexmedetomidine

Placebo OTHER

Placebo orally and intranasally

Placebo

Eligibility Criteria

• Age: 12 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital & Research Center

Riyadh, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Postoperative Complications

Interventions

Midazolam; Dexmedetomidine

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Ganesh Sivasankara, MBBS

  King Faisal Specialist Hospital & Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Engborg, MD

CONTACT

+966555327987; lengborg@kfshrc.edu.sa

Dean Turina, MD BSc

CONTACT

+966500343041; dturina8@kfshrc.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Anesthesiology

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 22, 2020
• Study Start: October 17, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

SA (1)