Study Summary
This trial found that preoperative use of intra-nasal Dexmedetomidine and oral Midazolam was effective in preventing emergent delirium in pediatric ambulatory surgery.
- Pediatric Delirium
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 7 Secondary · Reporting Duration: 12-48 hours
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Oral Midazolam
1 of 2
Intra-nasal Dexmedetomidine
1 of 2
Active Control
Experimental Treatment
60 Total Participants · 2 Treatment Groups
Primary Treatment: Intra-nasal Dexmedetomidine · No Placebo Group · Phase 4
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 3 - 9 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Is there a risk of adverse reactions when utilizing Intra-nasal Dexmedetomidine?
"Previously approved for use, Intra-nasal Dexmedetomidine is highly regarded medically and has been awarded a score of 3 on our safety scale." - Anonymous Online Contributor
Is this experiment currently admitting new participants?
"Evidenced on clinicaltrials.gov, this trial is actively recruiting participants as of June 1st 2022 - having first been posted to the website on April 27th 2021." - Anonymous Online Contributor
Is participation in this study open to seniors aged 65 and above?
"This clinical trial is targeting patients between 3 months and 9 years old. There are 64 distinct trials for those under 18, while 241 studies relate to participants over the age of 65." - Anonymous Online Contributor
What prior research has been conducted with respect to Intra-nasal Dexmedetomidine?
"Currently, 163 clinical trials are being conducted on Intra-nasal Dexmedetomidine. 30 of those studies have advanced to the third phase of development while 913 sites around the world are running such experiments with a significant concentration in Porto Alegre and California." - Anonymous Online Contributor
What are the key aims of this experiment?
"The primary metric of this trial, to be observed between 0 minutes and 48 hours, is the Duration of pediatric delirium. As secondary objectives, Drug Acceptance (defined as patient willingness in pre-operative area), Oral analgesic use (documented intake of oral medications such as acetaminophen or ibuprofen) and Rescue analgesia in PACU (quantity/dosage of rectal/oral acetaminophen given at post-anesthesia care unit) will also be tracked." - Anonymous Online Contributor
What medical purposes is Intra-nasal Dexmedetomidine most frequently prescribed for?
"Intra-nasal Dexmedetomidine is a preferred medication to treat anxiolysis. It can also provide relief from amnesia, convulsive seizures, and other anxiety disorders." - Anonymous Online Contributor
Is it possible to join this clinical trial?
"Sixty young patients who are between three months and nine years old and have delirium, scheduled for a myringotomy, will be accepted as participants in this research." - Anonymous Online Contributor
To what extent is this medical experiment being populated by participants?
"Affirmative, this clinical trial is currently seeking volunteers. According to information posted on clinicaltrials.gov, the research was first made public on April 27th 2021 and its details were last updated June 1st 2022. The study requires 60 participants from a single medical facility." - Anonymous Online Contributor