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

The Hospital for Sick Children

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Lidocaine; Drug: 24% Sucrose Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT00519207

1000010747

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 patients

Sex: All

Ages: 1 to 7 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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330 participants in 3 patient groups

1

Active Comparator group

Description:

This group will receive lidocaine and sucrose placebo (water).

Treatment:

Drug: Lidocaine

2

Active Comparator group

Description:

This group will receive lidocaine placebo and sucrose.

Treatment:

Drug: 24% Sucrose Solution

3

Active Comparator group

Description:

This group will receive lidocaine and sucrose.

Treatment:

Drug: 24% Sucrose Solution

Drug: Lidocaine