"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."
This study has been completed.
Sponsor:
State University of New York at Buffalo
Collaborator:
Ferndale Laboratories, Inc.
Information provided by:
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT00533468
First received: September 19, 2007
Last updated: March 23, 2011
Last verified: March 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 19, 2007 | ||||
| Last Updated Date | March 23, 2011 | ||||
| Start Date ICMJE | March 2007 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Neonatal Facial Coding System score [ Time Frame: Over the duration of the procedure ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Neonatal Facial Coding System score [ Time Frame: Over the duration of the procedure ] | ||||
| Change History | Complete list of historical versions of study NCT00533468 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
1. Time required to complete procedure from infant's presentation to the Emergency Department. 2. Success of the procedure [ Time Frame: Infant's stay in the Emergency Department ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
1. Time required to complete procedure from infant's presentation to the Emergency Department. 2. Success of the procedure [ Time Frame: Infant's stay in the Emergency Department ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | "Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age." | ||||
| Official Title ICMJE | "Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age." | ||||
| Brief Summary | The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap). |
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| Detailed Description | Pain of infants will be measured using the Neonatal Facial Coding System by videotaping the infant's face while they undergo the procedure. A comparison between the group that received active drug and the group that received placebo will allow a measurement of the difference, if any, of the pain experienced during the procedure of the infants. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
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| Condition ICMJE | Pain | ||||
| Intervention ICMJE | Drug: Lidocaine Cream 4%
Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure
Other Name: LMX4 |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 70 | ||||
| Completion Date | March 2008 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 60 Days | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00533468 | ||||
| Other Study ID Numbers ICMJE | 05-130 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | James Reingold, M.D., State University of New York at Buffalo | ||||
| Study Sponsor ICMJE | State University of New York at Buffalo | ||||
| Collaborators ICMJE | Ferndale Laboratories, Inc. | ||||
| Investigators ICMJE |
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| Information Provided By | State University of New York at Buffalo | ||||
| Verification Date | March 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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