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

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: 24% Sucrose Solution; Drug: Lidocaine

• Registration Number: NCT00519207
• Lead Sponsor: The Hospital for Sick Children

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-20
• Study First Submitted QC: 2007-08-20
• Study First Posted: 2007-08-22
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-18
• Last Update Posted: 2011-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	24% Sucrose Solution	This group will receive lidocaine placebo and sucrose.
3	24% Sucrose Solution	This group will receive lidocaine and sucrose.
1	Lidocaine	This group will receive lidocaine and sucrose placebo (water).
3	Lidocaine	This group will receive lidocaine and sucrose.

Primary Outcome Measures

Name	Time	Method
Infant pain during venipuncture as assessed by facial grimacing response.	During venipuncture

Secondary Outcome Measures

Name	Time	Method
Heart rate	During venipuncture
Visual Analog Scale scores	During venipuncture
Cry duration	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

Trial Locations

Locations (2)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada