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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: Completed Phase 4 study, sponsored by Akron Children's Hospital.

NCT00786916 is a Phase 4 study that has completed, run by Akron Children's Hospital. The registered enrollment target is 109 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

FLACC (Face, Legs, Activity, Cry, Consolability) Pain assessment scale was administered by a trained observer. The patient's parent documented maximum distress using a 100-mm visual analog scale where "0" represented "no pain" and 100 (the furthest point to the left) represented the worst pain ever.

Interventions

  • DRUG normal saline
  • DRUG lidocaine

Trial Details

FieldValue
Enrollment Target 109 participants
Start Date 2008-02
Est. Completion 2011-01
Phase Phase 4
Akron Children's Hospital

27 total trials

What the finished NCT00786916 record still lists

NCT00786916 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).

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

NCT00786916 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00786916's enrollment target sits among peer trials

109 737th of 2000 higher than 1,261 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 NCT00786916, the US trial registry maintained by the National Library of Medicine. NCT00786916 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.