Minimizing needle poke pain in newborn infants with a pain relieving cream and sugar water

ISRCTN	ISRCTN82181559
DOI	https://doi.org/10.1186/ISRCTN82181559
Protocol serial number	MCT-82947
Sponsor	The Hospital for Sick Children (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-82947)

Submission date: 22/08/2007
Registration date: 23/08/2007
Last edited: 18/04/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anna Taddio
Scientific

Department of Pharmacy and Child Health Evaluative Sciences
The Hospital for Sick Children
555 University Avenue
Toronto, Ontario
M5G 1X8
Canada

Phone	+1 416 783 5263
Email	anna.taddio@sickkids.ca

Study information

Primary study design	Interventional
Study design	Randomised, controlled, double-dummy, single-centre, three arm trial with study participant and investigator, caregiver, outcome assessor, and data analyst blinded.
Secondary study design	Randomised controlled trial
Scientific title	Evaluation of liposomal lidocaine and oral sucrose for treatment of pain in newborn infants undergoing venipuncture: a randomised controlled trial
Study objectives	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(s)	Ethics approval was gained from the Research Ethics Board of Mount Sinai Hospital Toronto, Ontario, Canada on August 03, 2007 (ref: 07-0099-A).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Liposomal lidocaine, oral sucrose
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	28/02/2010

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	330
Key inclusion criteria	All healthy full-term (greater than 37 weeks gestational age) newborn infants (either sex)
Key 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
Date of first enrolment	01/08/2007
Date of final enrolment	28/02/2010

Locations

Countries of recruitment

Canada

Study participating centre

Department of Pharmacy and Child Health Evaluative Sciences

Toronto, Ontario
M5G 1X8
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan