Intra-nasal Dexmedetomidine for Delirium

Phase-Based Progress Estimates
University of Massachusetts Medical School, Worcester, MADeliriumIntra-nasal Dexmedetomidine - Drug
3 - 9
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Pediatric Delirium

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: 12-48 hours

0-12 hours
End tidal Sevoflurane value
0-48 hours
Parental Separation Anxiety Scale (PSAS)
0-6 hours post surgery
Rescue analgesia in PACU
1-10 minutes prior to surgery
Mask Acceptance Scale
10-25 minutes prior to surgery
Drug Acceptance
12-48 hours
Home Behavior Analysis
Two days post-operative
Oral analgesic use
Hour 48
Duration of pediatric delirium
Time to offset of pediatric delirium
Time to onset of pediatric delirium

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

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

Intra-nasal Dexmedetomidine
Experimental Group · 1 Intervention: Intra-nasal Dexmedetomidine · Intervention Types: Drug
Oral Midazolam
ActiveComparator Group · 1 Intervention: Oral Midazolam · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12-48 hours

Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor
312 Previous Clinical Trials
753,799 Total Patients Enrolled
R. Ian Richmond, MDPrincipal Investigator - University of Massachusetts Chan Medical School
University of Massachusetts, Worcester

Eligibility Criteria

Age 3 - 9 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are planning to have ear surgery called myringotomy.

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

Unverified Answer

Is this experiment currently admitting new participants?

"Evidenced on, 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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

To what extent is this medical experiment being populated by participants?

"Affirmative, this clinical trial is currently seeking volunteers. According to information posted on, 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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.