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NCT00786916 · ClinicalTrials.gov registry record · Phase 4
Efficacy of IV Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Sedation
A Phase 4 study, sponsored by Akron Children's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 109
- Enrollment target
NCT00786916 is a Phase 4 study that has completed, run by Akron Children's Hospital. The registered enrollment target is 109 participants.
The verdict
NCT00786916, a Phase 4 study, has completed, sponsored by Akron Children's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 109 participants
- Enrollment target
Study Summary
This protocol describes a double-blind, placebo-controlled trial intended to demonstrate the effectiveness of lidocaine at reducing pain associated wiht propofol infusion for short-term deep sedation in children. Patients will be randomized to receive either placebo (saline) or one of two dosing regimens of IV lidocaine prior to initiating propofol infusion. The efficacy of the differing lidocaine doses will be compared to determine the minimum dose required to safely achieve alleviation of pain. We hypothesize that premedicating with lidocaine will significantly decrease pain experienced by pediatric patients receiving propofol for outpatient sedation.
Interventions
- DRUG normal saline
- DRUG lidocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2008-02 |
| Est. Completion | 2011-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00786916
The ClinicalTrials.gov registry entry for NCT00786916 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Akron Children's Hospital, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which normal saline is the first listed.
NCT00786916 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00786916 about?
NCT00786916 is a clinical study titled "Efficacy of IV Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Sedation". This protocol describes a double-blind, placebo-controlled trial intended to demonstrate the effectiveness of lidocaine at reducing pain associated wiht propofol infusion for short-term deep sedation in children. Patients will be randomized to receive either placebo (saline) or one of two dosing reg...
What is the current status of trial NCT00786916?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 109 participants. The study started on 2008-02. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00786916?
The interventions under investigation include: normal saline (DRUG), lidocaine (DRUG).
Who is sponsoring clinical trial NCT00786916?
This trial is sponsored by Akron Children's Hospital, which has 27 total clinical trials registered on ClinicalTrials.gov.
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