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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519207
• Other study ID #: 1000010747
• Status: Completed
• Phase: Phase 3
• First received: August 20, 2007
• Last updated: July 18, 2011
• Start date: August 2007
• Est. completion date: February 2009

Study information

• Verified date: July 2011
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant pain during venipuncture as assessed by facial grimacing response.		During venipuncture	No
Secondary	Visual Analog Scale scores		During venipuncture	No
Secondary	Cry duration		During venipuncture	No
Secondary	Heart rate		During venipuncture	No
Secondary	Number of attempts until procedure completion		From first needle poke to completion	No
Secondary	Endomorphins-1,-2 levels		Before and 10 minutes after sucrose/sucrose placebo administration	No
Secondary	Procedure duration		From first needle poke to completion	No
Secondary	Lidocaine levels		5-15 minutes after the study cream is removed	No