NCT00786916

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for phase_4 pain

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

February 27, 2015

Completed
Last Updated

February 27, 2015

Status Verified

February 1, 2015

Enrollment Period

2.9 years

First QC Date

November 5, 2008

Results QC Date

January 23, 2013

Last Update Submit

February 26, 2015

Conditions

Pain

Keywords

painpropofollidocainesedationpediatric

Outcome Measures

Primary Outcomes (1)

  • Maximal Pain/Discomfort

    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.

    during initial 3 minute propofol infusion

Study Arms (3)

Group A

PLACEBO COMPARATOR

Saline

Drug: normal saline

Group B

ACTIVE COMPARATOR

Lidocaine 0.25 mg/kg

Drug: lidocaine

Group C

ACTIVE COMPARATOR

Lidocaine 0.5 mg/kg

Drug: lidocaine

Interventions

normal salineDRUG

A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated.

Group A
lidocaineDRUG

A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated.

Group B

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • scheduled for painless diagnostic procedures
  • are ASA I or ASA II

You may not qualify if:

  • have an indwelling central venous catheter
  • have received an analgesic or sedative medication in the previous four hours prior to enrollment
  • have an underlying chronic disorder that would impact on their ability to express distress when in painful or otherwise anxiety-provoking situations
  • known hypersensitivity to lidocaine or any component of the formulation
  • hypersensitivity to another local anesthetic of the amide type
  • Adam-Stokes syndrome
  • severe degrees of SA, AV, or intraventricular heart block
  • allergy to corn-related products
  • contraindication to propofol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Saline SolutionLidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Limitations and Caveats

No complications or adverse reactions were associated with either study drug dose.

Results Point of Contact

Title
Michael D. Reed, Pharm.D.
Organization
Akron Children's Hospital
MReed@chmca.org
330-543-3193

Study Officials

  • Norman C Christopher, MD

    Akron Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharm.D.

Study Record Dates

First Submitted

November 5, 2008

First Posted

November 6, 2008

Study Start

February 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 27, 2015

Results First Posted

February 27, 2015

Record last verified: 2015-02

Locations

US(1)