CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Dexmedetomidine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04526652
NCT04526652Phase 2Completed

Evaluating Stress Response and Anxiety Score in Paediatric Patients Sedated With Intranasal Dexmedetomidine

Universiti Sains Malaysia·interventional·Posted Aug 26, 2020·Updated Oct 25, 2021

In Brief

A Phase 2 clinical trial evaluating Dexmedetomidine and Placebo for Anxiety and Fear and Anesthesia. Completed, enrolled 60 participants across 1 site.

Detailed Summary

To date, there have been no studies done relating serum cortisol levels and intranasal dexmedetomidine sedation. However, there was a behavioral study done on pediatric patients confirming reduction serum cortisol levels with perioperative dialogue intervention.There have been a number of studies done on adult patients indicating that dexmedetomidine was indeed capable of reducing level of anxiety with evidence of lower serum cortisol levels. Hence, we postulated that intranasal dexmedetomidine administration in pediatric patients will lower the serum cortisol levels but we need to evaluate the extent of reduction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMalaysia
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedAug 26, 2020
Enrollment StartDec 1, 2020
Primary CompletionJul 31, 2021
Study CompletionAug 1, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.9 years ago

Interventions

Dexmedetomidinedrug

Evaluating anxiety score in both arms

Placebodrug

Evaluating anxiety score in both arms