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NCT05934669 · ClinicalTrials.gov registry record · Phase 4
IN Midazolam vs IN Dexmedetomidine vs IN Ketamine During Minimal Procedures in Pediatric ED
A Phase 4 study of Anxiety and Laceration of Skin, sponsored by University of Oklahoma.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT05934669 is a Phase 4 study of Anxiety and Laceration of Skin that is actively recruiting participants, run by University of Oklahoma. The registered enrollment target is 90 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05934669, a Phase 4 study of Anxiety and Laceration of Skin, is actively recruiting participants, sponsored by University of Oklahoma.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
Pain in young children has been universally under-recognized due to their inability to describe or localize pain. Improvements in pharmacological interventions are necessary to optimize patient and family experience and allow for successful and efficient procedure completion. This is the first study that will compare three intranasal medications (Intranasal Midazolam, Dexmedetomidine, and Ketamine) to evaluate the length of stay after medication administration along with patient and provider satisfaction. The objective of this study is to demonstrate superior intranasal anxiolysis for pediatric laceration repairs with the shortest emergency department stay and highest patient and provider satisfaction. Based on previous studies and medication pharmacokinetics, we hypothesize that Intranasal Ketamine will have the shortest Emergency Department (ED) stay followed by Midazolam and then Dexmedetomidine with the longest stay; however, Dexmedetomidine will have the highest patient and provider satisfaction followed by Ketamine and then Midazolam.
Conditions Studied
Interventions
- DRUG Intranasal Midazolam
- DRUG Intranasal Dexmedetomidine
- DRUG Intranasal Ketamine
Study Locations (1)
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-11-14 |
| Est. Completion | 2025-06 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05934669
The ClinicalTrials.gov registry entry for NCT05934669 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (80% lower). The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Anxiety appearing as the primary indexed condition, and to 3 interventions - of which Intranasal Midazolam is the first listed.
NCT05934669 reports 1 study location spanning 1 distinct geographic area - top geographies include Oklahoma.
Frequently Asked Questions
What is clinical trial NCT05934669 about?
NCT05934669 is a clinical study titled "IN Midazolam vs IN Dexmedetomidine vs IN Ketamine During Minimal Procedures in Pediatric ED". Pain in young children has been universally under-recognized due to their inability to describe or localize pain. Improvements in pharmacological interventions are necessary to optimize patient and family experience and allow for successful and efficient procedure completion. This is the first study...
What is the current status of trial NCT05934669?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2023-11-14. Estimated completion is 2025-06.
What conditions does trial NCT05934669 study?
This clinical trial studies the following conditions: Anxiety, Laceration of Skin, Discharge Time.
What interventions are being tested in trial NCT05934669?
The interventions under investigation include: Intranasal Midazolam (DRUG), Intranasal Dexmedetomidine (DRUG), Intranasal Ketamine (DRUG).
Who is sponsoring clinical trial NCT05934669?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05934669 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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