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NCT02512783 · ClinicalTrials.gov registry record · NA
Decreasing Propofol Injection Pain by Pre-Treatment With Lidocaine in Pediatric Procedural Sedation
A NA study, sponsored by Children's Hospitals and Clinics of Minnesota.
- Terminated
- Registry status
- NA
- Development phase
- 171
- Enrollment target
NCT02512783: Clinical Trial NA study, sponsored by Children's Hospitals and Clinics of Minnesota.
NCT02512783 is a NA study that was terminated before completion, run by Children's Hospitals and Clinics of Minnesota. The registered enrollment target is 171 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02512783, a NA study, was terminated before completion, sponsored by Children's Hospitals and Clinics of Minnesota.
- TERMINATED
- Registry status
- NA
- Development phase
- 171 participants
- Enrollment target
Study Summary
This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.
Primary Outcome
The FLACC scale measures pain in children aged 2m-7y. The scale ranges from 0-10 with 0 being no pain. The total score out of 10 is based on 5 pieces of criteria, and each criteria is scored as either 0, 1, or 2. Scores on individual criteria are summed up to give a total score. Higher values represent a worse outcome of more pain. FLACC scores will be compared pre- and post-propofol induction to assess the change in FLACC score for each arm.
Interventions
- DRUG Lidocaine
- DRUG Propofol
- DRUG Normal Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-06 |
| Phase | NA |
Why NCT02512783 stopped before completion
NCT02512783 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Lidocaine is the first listed.
NCT02512783 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02512783 about?
NCT02512783 is a clinical study titled "Decreasing Propofol Injection Pain by Pre-Treatment With Lidocaine in Pediatric Procedural Sedation". This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction...
What is the current status of trial NCT02512783?
This trial is currently terminated. It is a NA study. The enrollment target is 171 participants. The study started on 2013-05. Estimated completion is 2014-06.
What interventions are being tested in trial NCT02512783?
The interventions under investigation include: Lidocaine (DRUG), Propofol (DRUG), Normal Saline (DRUG).
Who is sponsoring clinical trial NCT02512783?
This trial is sponsored by Children's Hospitals and Clinics of Minnesota, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02512783's enrollment target sits among peer trials
171 612th of 2000 higher than 1,387 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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