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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: Recruiting Phase 4 study of Anxiety and Laceration of Skin, sponsored by University of Oklahoma.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The nurse will document the time the medication is administered and the time of discharge once the patient meets American Academy of Pediatrics (AAP) criteria of discharge. AAP discharge criteria includes cardiovascular function and airway potency satisfactory; arousable and protective reflexes are intact; able to talk appropriately for age; able to sit up appropriately for age; and state of hydration is adequate
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 |
What NCT05934669 shows while recruiting
NCT05934669 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (80% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05934669's enrollment target sits among peer trials
90 184th of 364 higher than 178 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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