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RECRUITING Phase 4

IN Midazolam vs IN Dexmedetomidine vs IN Ketamine During Minimal Procedures in Pediatric ED

NCT05934669 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Intranasal Midazolam
  • DRUG Intranasal Dexmedetomidine
  • DRUG Intranasal Ketamine

Study Locations (1)

Oklahoma

  • University of Oklahoma Health Sciences Center — Oklahoma City

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2023-11-14
Est. Completion 2025-06
Phase Phase 4

Sponsor

University of Oklahoma

306 total trials

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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Oklahoma, which has 306 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05934669 reports 1 study location spanning 1 distinct geographic area — top geographies include Oklahoma. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05934669?

The interventions under investigation include: Intranasal Midazolam (DRUG), Intranasal Dexmedetomidine (DRUG), Intranasal Ketamine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05934669?

This trial is sponsored by University of Oklahoma, which has 306 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial