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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Lidocaine; Drug: 24% Sucrose Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1; This group will receive lidocaine and sucrose placebo (water).	Drug: Lidocaine; 1g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing.; Other Names: Maxilene 4
ACTIVE_COMPARATOR: 2; This group will receive lidocaine placebo and sucrose.	Drug: 24% Sucrose Solution; 2ml of 24% sucrose will be administered 2 minutes prior to venipuncture; Other Names: TootSweet
ACTIVE_COMPARATOR: 3; This group will receive lidocaine and sucrose.	Drug: Lidocaine; 1g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing.; Other Names: Maxilene 4; Drug: 24% Sucrose Solution; 2ml of 24% sucrose will be administered 2 minutes prior to venipuncture; Other Names: TootSweet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Infant pain during venipuncture as assessed by facial grimacing response.	During venipuncture

Secondary Outcome Measures

Outcome Measure	Time Frame
Visual Analog Scale scores	During venipuncture
Cry duration	During venipuncture
Heart rate	During venipuncture
Number of attempts until procedure completion	From first needle poke to completion
Endomorphins-1,-2 levels	Before and 10 minutes after sucrose/sucrose placebo administration
Procedure duration	From first needle poke to completion
Lidocaine levels	5-15 minutes after the study cream is removed

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Canadian Institutes of Health Research (CIHR)

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (ACTUAL): February 1, 2009
• Study Completion (ACTUAL): February 1, 2009

Study Registration Dates

• First Submitted: August 20, 2007
• First Submitted That Met QC Criteria: August 20, 2007
• First Posted (ESTIMATE): August 22, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): July 19, 2011
• Last Update Submitted That Met QC Criteria: July 18, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: pediatrics; pain; lidocaine; infants; venipuncture; sucrose; newborn screening
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 1000010747