Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519207
Status:
COMPLETED
Last Update Posted:
2011-07-19
First Post:
2007-08-20
Brief Title:
Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborns Undergoing Venipuncture
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborn Infants Undergoing Venipuncture A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to determine the relative efficacy of sucrose liposomal lidocaine and sucrose plus liposomal lidocaine on reducing pain during venipuncture in newborn infants
Detailed Description:
Despite the fact that modern medical practice is greatly advanced pain is inflicted on all Canadian newborn infants in the first days and months of life from blood tests injections and cannulations designed to prevent diagnose or manage medical conditions Procedural pain in newborn infants is a significant burden to infants their parents healthcare workers and society at large
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None