Efficacy of IV Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Sedation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Akron Children's Hospital.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Akron Children's Hospital
Information provided by:
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT00786916
First received: November 5, 2008
Last updated: January 21, 2011
Last verified: January 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: normal saline Drug: lidocaine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Efficacy of Intravenous Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Procedural Sedation |
Resource links provided by NLM:
Further study details as provided by Akron Children's Hospital:
Primary Outcome Measures:
- maximal pain/discomfort [ Time Frame: during initial 3 minute propofol infusion ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Group A
Saline
|
Drug: normal saline
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.
|
|
Active Comparator: Group B
Lidocaine 0.25 mg/kg
|
Drug: lidocaine
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.
|
|
Active Comparator: Group C
Lidocaine 0.5 mg/kg
|
Drug: lidocaine
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 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated.
|
Eligibility| Ages Eligible for Study: | 2 Years to 7 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- scheduled for painless diagnostic procedures
- are ASA I or ASA II
Exclusion Criteria:
- 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 painfulr 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786916
Locations
| United States, Ohio | |
| Akron Children's Hospital | |
| Akron, Ohio, United States, 44308 | |
Sponsors and Collaborators
Akron Children's Hospital
Investigators
| Principal Investigator: | Norman C Christopher, MD | Akron Children's Hospital |
More Information
No publications provided
| Responsible Party: | Norman Christopher, M.D., Akron Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT00786916 History of Changes |
| Other Study ID Numbers: | 080209 |
| Study First Received: | November 5, 2008 |
| Last Updated: | January 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Akron Children's Hospital:
|
pain propofol lidocaine sedation pediatric |
Additional relevant MeSH terms:
|
Lidocaine Propofol Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents |
Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents Anesthetics, Intravenous Anesthetics, General Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on May 19, 2013