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

Condition(s) targeted: Pain

Intervention: Lidocaine (Drug); 24% Sucrose Solution (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: The Hospital for Sick Children

Official(s) and/or principal investigator(s):
Anna Taddio, PhD, Principal Investigator, Affiliation: The Hospital for Sick Children, Toronto Canada

Overall contact:
Anna Taddio, PhD, Phone: 416-813-6235, Email: anna.taddio@sickkids.ca

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Infant pain during venipuncture as assessed by facial grimacing response.

Secondary outcome:

Visual Analog Scale scores

Cry duration

Heart rate

Number of attempts until procedure completion

Endomorphins-1,-2 levels

Procedure duration

Lidocaine levels

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.

Minimum age: N/A. Maximum age: 7 Days. Gender(s): Both.

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.

Anna Taddio, PhD, Phone: 416-813-6235, Email: anna.taddio@sickkids.ca

The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Recruiting
Anna Taddio, PhD, Phone: 416 813 6235, Email: anna.taddio@sickkids.ca
Anna Taddio, PhD, Principal Investigator
Gideon Koren, MD, Sub-Investigator
Derek Stephens, MSc, Sub-Investigator

Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada; Recruiting
Vibhuti Shah, MD, Phone: 416 586 4816, Email: vshah@mtsinai.on.ca
Vibhuti Shah, MD, Principal Investigator
Joel Katz, PhD, Sub-Investigator

Starting date: August 2007
Ending date: June 2009
Last updated: May 22, 2008