Clinical trial NCT00519207: Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborns Undergoing Venipuncture
Official title: Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborn Infants Undergoing Venipuncture: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: pediatrics
pain
infants
newborn screening
venipuncture
lidocaine
sucrose
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2007-08-22
Enrollment: 330
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Infant pain during venipuncture as assessed by facial grimacing response.
timeFrame: During venipuncture
Secondary outcomes:
measure: Visual Analog Scale scores
timeFrame: During venipuncture
measure: Cry duration
timeFrame: During venipuncture
measure: Heart rate
timeFrame: During venipuncture
measure: Number of attempts until procedure completion
timeFrame: From first needle poke to completion
measure: Endomorphins-1,-2 levels
timeFrame: Before and 10 minutes after sucrose/sucrose placebo administration
measure: Procedure duration
timeFrame: From first needle poke to completion
measure: Lidocaine levels
timeFrame: 5-15 minutes after the study cream is removed
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References: