Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborns Undergoing Venipuncture
NCT ID: NCT00519207
Last Updated: 2011-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
330 participants
INTERVENTIONAL
2007-08-31
2009-02-28
Brief Summary
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Detailed Description
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This study proposes a large randomized controlled trial to determine the optimal analgesic regimen for procedural pain using methods that can be easily implemented in clinical practice. We will study liposomal lidocaine cream and sucrose oral liquid, used alone, or together, to manage procedural pain. Liposomal lidocaine is a relatively new anaesthetic formulation ideally suited for young infants due to the established role of lidocaine in neonatal clinical medicine. Sucrose (sugar water) reduces pain responses and is promoted in consensus guidelines developed by pain experts. However, it is perceived by many front-line clinicians to be simply a comforting agent rather than a true analgesic. Studying liposomal lidocaine and sucrose together is important since the combination may prove superior to either agent alone, and may even prevent or abolish pain from clinical procedures.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
This group will receive lidocaine and sucrose placebo (water).
Lidocaine
1g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing.
2
This group will receive lidocaine placebo and sucrose.
24% Sucrose Solution
2ml of 24% sucrose will be administered 2 minutes prior to venipuncture
3
This group will receive lidocaine and sucrose.
Lidocaine
1g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing.
24% Sucrose Solution
2ml of 24% sucrose will be administered 2 minutes prior to venipuncture
Interventions
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Lidocaine
1g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing.
24% Sucrose Solution
2ml of 24% sucrose will be administered 2 minutes prior to venipuncture
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥ 37 weeks gestational age.
Exclusion Criteria
* asphyxia, seizures
* major birth defect (heart, brain, genetic syndrome)
* circumcised during study
* receiving analgesia/sedatives.
1 Day
7 Days
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
The Hospital for Sick Children
OTHER
Responsible Party
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The Hospital for Sick Children
Principal Investigators
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Anna Taddio, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children, Toronto Canada
Locations
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Mount Sinai Hospital
Toronto, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Other Identifiers
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1000010747
Identifier Type: -
Identifier Source: org_study_id
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