NCT00519207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P50-P75 for phase_3 pain

Timeline
Completed

Started Aug 2007

Typical duration for phase_3 pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

July 19, 2011

Status Verified

July 1, 2011

Enrollment Period

1.5 years

First QC Date

August 20, 2007

Last Update Submit

July 18, 2011

Conditions

Pain

Keywords

pediatricspaininfantsnewborn screeningvenipuncturelidocainesucrose

Outcome Measures

Primary Outcomes (1)

  • Infant pain during venipuncture as assessed by facial grimacing response.

    During venipuncture

Secondary Outcomes (7)

  • Visual Analog Scale scores

    During venipuncture

  • Cry duration

    During venipuncture

  • Heart rate

    During venipuncture

  • Number of attempts until procedure completion

    From first needle poke to completion

  • Endomorphins-1,-2 levels

    Before and 10 minutes after sucrose/sucrose placebo administration

  • +2 more secondary outcomes

Study Arms (3)

1

ACTIVE COMPARATOR

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

Drug: Lidocaine

2

ACTIVE COMPARATOR

This group will receive lidocaine placebo and sucrose.

Drug: 24% Sucrose Solution

3

ACTIVE COMPARATOR

This group will receive lidocaine and sucrose.

Drug: LidocaineDrug: 24% Sucrose Solution

Interventions

LidocaineDRUG

1g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing.

Also known as: Maxilene 4
13
24% Sucrose SolutionDRUG

2ml of 24% sucrose will be administered 2 minutes prior to venipuncture

Also known as: TootSweet
23

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Healthy newborn infants
  • ≥ 37 weeks gestational age.

You may not qualify if:

  • neonatal intensive care unit (NICU) admission
  • asphyxia, seizures
  • major birth defect (heart, brain, genetic syndrome)
  • circumcised during study
  • receiving analgesia/sedatives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Pain

Interventions

LidocaineSucrose

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Anna Taddio, PhD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2007

First Posted

August 22, 2007

Study Start

August 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

July 19, 2011

Record last verified: 2011-07

Locations

CA(2)