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

NCT04356638 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-11-24

No results posted yet for this study

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

Interventions

DRUG

Midazolam

Oral Midazolam and intranasal placebo

DRUG

Dexmedetomidine

Intranasal Dexmedetomidine and oral placebo

OTHER

Placebo

Placebo orally and intranasally

Sponsors & Collaborators

  • King Faisal Specialist Hospital & Research Center

    lead OTHER

Principal Investigators

  • Ganesh Sivasankara, MBBS · King Faisal Specialist Hospital & Research Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-17
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04356638 on ClinicalTrials.gov