Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborns Undergoing Venipuncture

• Visual Analog Scale scores [ Time Frame: During venipuncture ] [ Designated as safety issue: No ]
• Cry duration [ Time Frame: During venipuncture ] [ Designated as safety issue: No ]
• Heart rate [ Time Frame: During venipuncture ] [ Designated as safety issue: No ]
• Number of attempts until procedure completion [ Time Frame: From first needle poke to completion ] [ Designated as safety issue: No ]
• Endomorphins-1,-2 levels [ Time Frame: Before and 10 minutes after sucrose/sucrose placebo administration ] [ Designated as safety issue: No ]
• Procedure duration [ Time Frame: From first needle poke to completion ] [ Designated as safety issue: No ]
• Lidocaine levels [ Time Frame: 5-15 minutes after the study cream is removed ] [ Designated as safety issue: No ]

• 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 ]

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.

• Drug: Lidocaine
  1g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing.
  Other Name: Maxilene 4
• Drug: 24% Sucrose Solution
  2ml of 24% sucrose will be administered 2 minutes prior to venipuncture
  Other Name: TootSweet

• Active Comparator: 1
  This group will receive lidocaine and sucrose placebo (water).
  Intervention: Drug: Lidocaine
• Active Comparator: 2
  This group will receive lidocaine placebo and sucrose.
  Intervention: Drug: 24% Sucrose Solution
• Active Comparator: 3
  This group will receive lidocaine and sucrose.
  Interventions:

  • Drug: Lidocaine
  • Drug: 24% Sucrose Solution

Inclusion Criteria:

• Healthy newborn infants
• ≥ 37 weeks gestational age.

Exclusion Criteria:

• neonatal intensive care unit (NICU) admission
• asphyxia, seizures
• major birth defect (heart, brain, genetic syndrome)
• circumcised during study
• receiving analgesia/sedatives.