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NCT03054844 · ClinicalTrials.gov registry record · Phase 2
PREMIX vs PREMED Intranasal Lidocaine and Midazolam
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT03054844 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 55 participants.
The verdict
NCT03054844, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
Intranasal (IN) midazolam is an anxiolytic that is commonly used in the pediatric population for procedural anxiolysis in the emergency department (ED) setting to facilitate painful and distressing procedures, such as laceration repairs. Intranasal midazolam is both effective and safe in children. However, due to the acidic nature of midazolam, there is a burning sensation that is associated with the intranasal administration of midazolam. The use of IN lidocaine has been shown to decrease the pain associated with the administration of IN midazolam and other acidic solutions. The IN lidocaine can be given as a premedication (PREMED), where it is sprayed in the nares first to provide topical anesthesia, and then followed by the administration of the IN midazolam. Lidocaine can also be given concurrently with the IN midazolam (PREMIX), where it is mixed with the midazolam and then the combined mixture administered. Both methods have been shown to be effective in decreasing the pain associated with the intranasal administration of acidic solutions, such as midazolam, although the PREMIX method could have the advantage of requiring less number of sprays, and be tolerated better by children. Although both methods have been shown to work, it is not known if the PREMIX method is non-inferior to the PREMED method for decreasing pain and distress associated with administering IN midazolam. Therefore, the investigators aim to determine if the PREMIX method is non-inferior to the PREMED method of using lidocaine to decrease the pain and distress associated with the administration of IN midazolam in children.
Interventions
- DRUG Midazolam
- DRUG Lidocaine
- DRUG Lidocaine and midazolam (PREMIX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2017-04-03 |
| Est. Completion | 2017-10-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03054844
The ClinicalTrials.gov registry entry for NCT03054844 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Midazolam is the first listed.
NCT03054844 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03054844 about?
NCT03054844 is a clinical study titled "PREMIX vs PREMED Intranasal Lidocaine and Midazolam". Intranasal (IN) midazolam is an anxiolytic that is commonly used in the pediatric population for procedural anxiolysis in the emergency department (ED) setting to facilitate painful and distressing procedures, such as laceration repairs. Intranasal midazolam is both effective and safe in children. H...
What is the current status of trial NCT03054844?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2017-04-03. Estimated completion is 2017-10-10.
What interventions are being tested in trial NCT03054844?
The interventions under investigation include: Midazolam (DRUG), Lidocaine (DRUG), Lidocaine and midazolam (PREMIX) (DRUG).
Who is sponsoring clinical trial NCT03054844?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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