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Alpha-2 Agonist

Dexmedetomidine + Midazolam for Pediatric Delirium

Phase 4
Recruiting
Led By R. Ian Richmond, MD
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-48 hours
Awards & highlights

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.

Who is the study for?
This trial is for children aged 3 months to 9 years who are scheduled for ear surgery (myringotomy) and are generally healthy (ASA class I-II). It's not for kids over age 9, those with serious heart defects, or non-English speakers without short form consent.Check my eligibility
What is being tested?
The study tests if using intra-nasal Dexmedetomidine or oral Midazolam before surgery can prevent confusion and agitation (delirium) in kids after they wake up from anesthesia in outpatient ear surgeries.See study design
What are the potential side effects?
Possible side effects of Dexmedetomidine include low blood pressure, slow heart rate, dry mouth, and nausea. Midazolam may cause drowsiness, headache, vomiting, and mood changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two days post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and two days post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of pediatric delirium
Time to offset of pediatric delirium
Time to onset of pediatric delirium
Secondary outcome measures
Drug Acceptance
End tidal Sevoflurane value
Home Behavior Analysis
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intra-nasal DexmedetomidineExperimental Treatment1 Intervention
Subjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room.
Group II: Oral MidazolamActive Control1 Intervention
Subjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room.

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Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor
342 Previous Clinical Trials
976,550 Total Patients Enrolled
2 Trials studying Delirium
258 Patients Enrolled for Delirium
R. Ian Richmond, MDPrincipal Investigator - University of Massachusetts Chan Medical School
University of Massachusetts, Worcester

Media Library

Delirium Research Study Groups: Intra-nasal Dexmedetomidine, Oral Midazolam
Delirium Clinical Trial 2023: Dexmedetomidine Highlights & Side Effects. Trial Name: NCT04669457 — Phase 4
Dexmedetomidine (Alpha-2 Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04669457 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pediatric Delirium
R. Ian Richmond 2021. "Pediatric Delirium". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04669457.
~15 spots leftby Apr 2025
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