Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborns Undergoing Venipuncture - Full Text View

Sponsors and Collaborators:	The Hospital for Sick Children Canadian Institutes of Health Research (CIHR)
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00519207

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: Lidocaine Drug: 24% Sucrose Solution	Phase III

Drug Information available for: Lidocaine Sucrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborn Infants Undergoing Venipuncture: A Randomized Controlled Trial

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

Infant pain during venipuncture as assessed by facial grimacing response. [ Time Frame: During venipuncture ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	330
Study Start Date:	August 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator This group will receive lidocaine placebo and sucrose.	Drug: 24% Sucrose Solution 2ml of 24% sucrose will be administered 2 minutes prior to venipuncture
3: Active Comparator 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. Drug: 24% Sucrose Solution 2ml of 24% sucrose will be administered 2 minutes prior to venipuncture

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.

Eligibility

Ages Eligible for Study:	up to 7 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519207

Contacts

Contact: Anna Taddio, PhD

416-813-6235

anna.taddio@sickkids.ca

Locations

Canada, Ontario
The Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Anna Taddio, PhD 416 813 6235 anna.taddio@sickkids.ca
Principal Investigator: Anna Taddio, PhD
Sub-Investigator: Gideon Koren, MD
Sub-Investigator: Derek Stephens, MSc
Mount Sinai Hospital	Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Vibhuti Shah, MD 416 586 4816 vshah@mtsinai.on.ca
Principal Investigator: Vibhuti Shah, MD
Sub-Investigator: Joel Katz, PhD

Sponsors and Collaborators

The Hospital for Sick Children

Canadian Institutes of Health Research (CIHR)

Investigators

Principal Investigator:

Anna Taddio, PhD

The Hospital for Sick Children, Toronto Canada

More Information

Responsible Party:	The Hospital for Sick Children ( Anna Taddio/Principal Investigator )
Study ID Numbers:	1000010747
Study First Received:	August 20, 2007
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00519207
Health Authority:	Canada: Health Canada

Keywords provided by The Hospital for Sick Children:

pediatrics
pain
infants
newborn screening

venipuncture
lidocaine
sucrose

Study placed in the following topic categories:

Lidocaine
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents

Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 15, 2009