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NCT02168439 · ClinicalTrials.gov registry record · Phase 4

Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair

A Phase 4 study, sponsored by University of Pittsburgh.

Completed
Registry status
Phase 4
Development phase
40
Enrollment target

NCT02168439: Completed Phase 4 study, sponsored by University of Pittsburgh.

NCT02168439 is a Phase 4 study that has completed, run by University of Pittsburgh. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02168439, a Phase 4 study, has completed, sponsored by University of Pittsburgh.

COMPLETED
Registry status
Phase 4
Development phase
40 participants
Enrollment target

Study Summary

The objective of this research study is to show superiority of intranasal dexmedetomidine to intranasal midazolam as anxiolysis prior to pediatric laceration repairs.

Primary Outcome

Primary outcome was the mYPAS scores at the time of positioning for procedure. mYPAS stands for modified Yale Preoperative anxiety scale. The scale is from minimum 23.3- maximum 100. Higher scores indicate higher anxiety. By prior characterization, scores less than or equal to 30 are classified as not anxious.

Interventions

  • DRUG Midazolam
  • DRUG Dexmedetomidine

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2014-06
Est. Completion 2016-06
Phase Phase 4
University of Pittsburgh

1,238 total trials

What the finished NCT02168439 record still lists

NCT02168439 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.

NCT02168439 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02168439 about?

NCT02168439 is a clinical study titled "Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair". The objective of this research study is to show superiority of intranasal dexmedetomidine to intranasal midazolam as anxiolysis prior to pediatric laceration repairs.

What is the current status of trial NCT02168439?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2014-06. Estimated completion is 2016-06.

What interventions are being tested in trial NCT02168439?

The interventions under investigation include: Midazolam (DRUG), Dexmedetomidine (DRUG).

Who is sponsoring clinical trial NCT02168439?

This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02168439's enrollment target sits among peer trials

40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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

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Source: ClinicalTrials.gov NCT02168439, the US trial registry maintained by the National Library of Medicine. NCT02168439 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.