Condition category
Signs and Symptoms
Date applied
22/08/2007
Date assigned
23/08/2007
Last edited
18/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.sickkids.ca/

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

Publication citations

Additional files

Editorial Notes