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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
330
1g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing.
2ml of 24% sucrose will be administered 2 minutes prior to venipuncture
Mount Sinai Hospital
Toronto, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Infant pain during venipuncture as assessed by facial grimacing response.
Time frame: During venipuncture
Visual Analog Scale scores
Time frame: During venipuncture
Cry duration
Time frame: During venipuncture
Heart rate
Time frame: During venipuncture
Number of attempts until procedure completion
Time frame: From first needle poke to completion
Endomorphins-1,-2 levels
Time frame: Before and 10 minutes after sucrose/sucrose placebo administration
Procedure duration
Time frame: From first needle poke to completion
Lidocaine levels
Time frame: 5-15 minutes after the study cream is removed
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