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

Overview

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.

Full Title of Study: “Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborn Infants Undergoing Venipuncture: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2009

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.

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: 1
    • This group will receive lidocaine and sucrose placebo (water).
  • Active Comparator: 2
    • This group will receive lidocaine placebo and sucrose.
  • Active Comparator: 3
    • This group will receive lidocaine and sucrose.

Clinical Trial Outcome Measures

Primary Measures

  • Infant pain during venipuncture as assessed by facial grimacing response.
    • Time Frame: During venipuncture

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 7 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Hospital for Sick Children
  • Collaborator
    • Canadian Institutes of Health Research (CIHR)
  • Provider of Information About this Clinical Study
    • Anna Taddio/Principal Investigator, The Hospital for Sick Children
  • Overall Official(s)
    • Anna Taddio, PhD, Principal Investigator, The Hospital for Sick Children, Toronto Canada

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