Contact information
Type
Scientific
Primary contact
Dr Anna Taddio
ORCID ID
Contact details
Department of Pharmacy and Child Health Evaluative Sciences
The Hospital for Sick Children
555 University Avenue
Toronto
Ontario
M5G 1X8
Canada
+1 416 783 5263
anna.taddio@sickkids.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-82947
Study information
Scientific title
Evaluation of liposomal lidocaine and oral sucrose for treatment of pain in newborn infants undergoing venipuncture: a randomised controlled trial
Acronym
Study hypothesis
Public title: Minimising needle poke pain in newborn infants with a pain relieving cream and sugar water
Hypothesis 1: Sucrose plus liposomal lidocaine will be superior to either agent alone in reducing pain during venipuncture.
Hypothesis 2: Plasma levels of lidocaine will be below toxicologically significant levels (1 mcg/ml), providing objective evidence of safety.
Hypothesis 3: Plasma levels of endomorphins-1,-2 will be higher in infants pre-medicated with sucrose versus lidocaine, confirming that sucrose exerts its analgesic effects via an opioid-mediated mechanism.
Ethics approval
Ethics approval was gained from the Research Ethics Board of Mount Sinai Hospital Toronto, Ontario, Canada on August 03, 2007 (ref: 07-0099-A).
Study design
Randomised, controlled, double-dummy, single-centre, three arm trial with study participant and investigator, caregiver, outcome assessor, and data analyst blinded.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Newborns undergoing painful procedure
Intervention
Experimental arm one: 1 g of liposomal lidocaine to the dorsum of hand for 30 - 40 minutes prior to venipuncture and 2 ml of placebo water by mouth using a syringe over 1 - 2 minutes prior to venipuncture.
Experimental arm two: 2 ml of 24% sucrose administered by mouth using a syringe over 1 - 2 minutes prior to venipuncture and 1 g of placebo liposomal lidocaine to the dorsum of hand for 30 - 40 minutes prior to venipuncture.
Experimental arm three: both 1 g of liposomal lidocaine to the dorsum of hand for 30 - 40 minutes prior to venipuncture and 2 ml of 24% sucrose administered by mouth using a syringe over 1 - 2 minutes prior to venipuncture.
Due to double dummy, all infants receive oral sucrose or water (placebo) and all infants receive liposomal lidocaine or placebo. Each baby gets one intervention (experimental arm 1, 2, or 3).
Intervention type
Drug
Phase
Not Specified
Drug names
Liposomal lidocaine, oral sucrose
Primary outcome measures
Infant pain during venipuncture as assessed by facial grimacing response - the score will incorporate three facial actions: brow bulge, eye squeezed shut, naso-labial furrow, during venipuncture.
Secondary outcome measures
1. Visual Analog Scale (VAS), during venipuncture
2. Cry duration, during venipuncture
3. Heart rate, during venipuncture
4. Number of attempts until procedure completion, from first needle poke to completion
5. Endomorphins -1, -2, levels, before and 10 minutes after sucrose/sucrose placebo administration
6. Procedure duration, from first needle poke to completion
7. Lidocaine levels, 5 - 15 minutes after the liposomal lidocaine cream/placebo cream is removed
Overall trial start date
01/08/2007
Overall trial end date
28/02/2010
Reason abandoned
Eligibility
Participant inclusion criteria
All healthy full-term (greater than 37 weeks gestational age) newborn infants (either sex)
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
330
Participant exclusion criteria
1. Neonatal Intensive Care Unit (NICU) admission
2. Asphyxia, seizures
3. Major birth defects (heart, brain, genetic syndrome)
4. Circumcised during study
5. Receiving analgesia/sedatives
Recruitment start date
01/08/2007
Recruitment end date
28/02/2010
Locations
Countries of recruitment
Canada
Trial participating centre
Department of Pharmacy and Child Health Evaluative Sciences
Toronto, Ontario
M5G 1X8
Canada
Sponsor information
Organisation
The Hospital for Sick Children (Canada)
Sponsor details
c/o Ms. Julie Gibson
Manager
Clinical Research Office
555 University Avenue
Toronto
Ontario
M5G 1X8
Canada
+1 416 813 8481
julie.gibson@sickkids.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-82947)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary