Condition category
Signs and Symptoms
Date applied
29/07/2005
Date assigned
04/11/2005
Last edited
29/03/2006
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 Brigitte Lemyre

ORCID ID

Contact details

401 Smyth Road
Ottawa
K1H 8L1
Canada
blemyre@ottawahospital.on.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BL 002

Study information

Scientific title

Acronym

Study hypothesis

Amethocaine 4% gel applied before a venipuncture in newborn infants will safely and significantly decrease procedural pain

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Procedural pain

Intervention

Ametop (amethocaine) 4% gel versus placebo, 1.5 g applied to skin for 30 minutes prior to the venipuncture

Intervention type

Drug

Phase

Not Specified

Drug names

Ametop (amethocaine) 4% gel

Primary outcome measures

Premature Infant Pain Profile (PIPP) score in the first minute after skin puncture

Secondary outcome measures

1. PIPP scores during the first, second, third and fourth minute post-skin puncture
2. Mean heart rate in beats per minute, mean respiratory rate per minute, mean blood pressure in mm Hg and mean 02 saturation in % at the end of baseline, 1 minute after skin puncture then 2, 3, 4, 5 and 10 minutes after skin puncture
3. Duration of cry, from skin puncture to recovery
4. Ease of procedure, as reflected by the mean number of attempts required to obtain the bloodwork, the success rate at obtaining the bloodwork and subjective measure of easiness on a scale of 1 to 5 (1 being very easy and 5 very hard)

The safety of amethocaine was assessed using the following data: local skin reaction (redness, edema), complete blood count and differential (pre and post intervention), aspartate aminotransferase (AST) and ALT (pre and post intervention), and creatinine levels (post intervention). All infants’ vital signs were monitored throughout and after the intervention and any significant event (apnea/bradycardia, sustained bradycardia or tachycardia, sustained desaturation requiring intervention) was recorded.

Overall trial start date

03/01/2003

Overall trial end date

30/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Born at >24 weeks gestation
2. Skin considered in good condition (no burns or rash)
3. If <27 weeks gestation, at least 48 hours of life
4. Considered stable by the treating neonatologist

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

54

Participant exclusion criteria

1. Skin considered immature (insensible water losses requiring more fluids than usual for gestation)
2. Suspected or proven significant central nervous system anomaly
3. Receiving opioids or sedatives at time of venipuncture or in the previous 12 hours or receiving muscle relaxants
4. Facial anomalies (cleft lip/palate, Moebius syndrome) preventing typical facial expression of pain
5. Sub optimal hepatic function (alanine aminotransferase [ALT] >2 x upper normal limit) or sub optimal renal function (urine output <1 ml/kg/hour in the last 12 hours)

Recruitment start date

03/01/2003

Recruitment end date

30/12/2004

Locations

Countries of recruitment

Canada

Trial participating centre

401 Smyth Road
Ottawa
K1H 8L1
Canada

Sponsor information

Organisation

Children's Hospital of Eastern Ontario Research Institute (Canada)

Sponsor details

401 Smyth Road
Ottawa
K1H 8L1
Canada
blemyre@ottawahospital.on.ca

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Physicians Services Incorporated (#02-39) and Children's Hospital of Eastern Ontario Research Institute

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