Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04586504 · ClinicalTrials.gov registry record · Phase 1
Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children
A Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 1
- Development phase
- 101
- Enrollment target
NCT04586504: Completed Phase 1 study, sponsored by Columbia University.
NCT04586504 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 101 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04586504, a Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 101 participants
- Enrollment target
Study Summary
Dose-finding study to compare intranasal midazolam doses of 0.2, 0.3, 0.4 and 0.5 mg/kg in children undergoing laceration repair to achieve the following aims: Specific Aim #1: To determine the most effective dose of intranasal midazolam for producing adequate sedation state associated with each dose. Specific Aim #2: To determine the time to recovery and describe the adverse events associated with each dose.
Primary Outcome
The Pediatric Sedation State Scale (PSSS) is scored from 0 to 5, representing a continuum of sedation that spans from over-sedation associated with changes in vital signs (0) to inadequate sedation (5).
Interventions
- DRUG Intranasal midazolam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2021-09-08 |
| Est. Completion | 2024-05-14 |
| Phase | Phase 1 |
What the finished NCT04586504 record still lists
NCT04586504 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% higher).
The record links to 0 conditions, and to 1 intervention - of which Intranasal midazolam is the first listed.
NCT04586504 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04586504 about?
NCT04586504 is a clinical study titled "Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children". Dose-finding study to compare intranasal midazolam doses of 0.2, 0.3, 0.4 and 0.5 mg/kg in children undergoing laceration repair to achieve the following aims: Specific Aim #1: To determine the most effective dose of intranasal midazolam for producing adequate sedation state associated with each do...
What is the current status of trial NCT04586504?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 101 participants. The study started on 2021-09-08. Estimated completion is 2024-05-14.
What interventions are being tested in trial NCT04586504?
The interventions under investigation include: Intranasal midazolam (DRUG).
Who is sponsoring clinical trial NCT04586504?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04586504's enrollment target sits among peer trials
101 546th of 2000 higher than 1,455 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04033497 · 101 participants · NA
Treatment Response Assessment Maps to Delineate Necrosis From Tumor After Stereotactic Radiation in Brain Metastases
- NCT05111574 · 101 participants · Phase 2
Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery
- NCT05984680 · 101 participants
COPD Care Pathway Among Patients With Cancer
- NCT06266299 · 101 participants · Phase 1
A Study of KK2269 in Adult Participants With Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI