Condition category
Neonatal Diseases
Date applied
18/11/2005
Date assigned
18/11/2005
Last edited
06/03/2009
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

FRN: 59754

Study information

Scientific title

How effective is 4% Ametop gel applied before a percutaneously inserted central catheter (PICC) in reducing procedural pain in infants: a randomised placebo controlled trial

Acronym

Study hypothesis

To compare multidimensional pain scores as measured with the premature infant pain profile (PIPP) during insertion of a PICC in infants randomised to Ametop (Ametocaine) or placebo.

Ethics approval

The Ottawa Hospital Research Ethics Board gave approval on the 27th June 2002.

Study design

Randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Procedural pain in premature infants

Intervention

Treatment group: Amethocaine 4% gel, 1.5 g, applied for 30 minutes before the PICC insertion

Placebo group: placebo gel (professional skin care lotion, Smith-Nephew), 1.5 g applied for 30 minutes before the PICC insertion

Intervention type

Drug

Phase

Not Applicable

Drug names

Ametop

Primary outcome measures

Premature Infant Pain Profile (PIPP) score at 1 minute

Secondary outcome measures

1. PIPP scores at 1, 2, 3 and 4 minutes after the PICC
2. Physiological indicators of pain (HR, Sa02, BP, RR) at 1, 2, 3, 4, 5 and 10 minutes
3. Duration of cry in seconds from PICC insertion to recovery, number of attempts and success rate at inserting the PICC.
4. Safety: local skin reaction (redness, edema), significant changes in the complete blood count (CBC), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine before (within 48 hours) and after (within 48 hours) the intervention

Overall trial start date

18/12/2002

Overall trial end date

26/07/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Born at greater than or equal to 24 weeks gestation
2. Infants 24 - 40 weeks gestational age, either sex
3. With skin considered in good condition (no burns or rash)
4. When less than 27 weeks gestation, must be greater than or equal to 48 hours of life
5. Considered stable by treating neonatologist
6. With informed consent by a parent or legal guardian

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

54

Participant exclusion criteria

1. Skin considered immature
2. Suspected or proven significant central nervous system anomaly
3. Infants receiving opioids or sedatives at time of PICC insertion or in the previous 12 hours or infants receiving muscle relaxants
4. Infants with facial anomalies preventing typical facial expression of pain
5. Infants with sub optimal hepatic function (alanine aminotransferase [ALT] 2 x upper normal limit) or sub-optimal renal function
6. Parents or legal guardian have refused consent

Recruitment start date

18/12/2002

Recruitment end date

26/07/2004

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 (CHEORI) (Canada)

Sponsor details

401 Smith Rd
Ottawa
K1H 8L1
Canada

Sponsor type

Hospital/treatment centre

Website

http://www.cheori.org/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: FRN: 59754)

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16672064

Publication citations

  1. Results

    Lemyre B, Sherlock R, Hogan D, Gaboury I, Blanchard C, Moher D, How effective is tetracaine 4% gel, before a peripherally inserted central catheter, in reducing procedural pain in infants: a randomized double-blind placebo controlled trial [ISRCTN75884221]., BMC Med, 2006, 4, 11, doi: 10.1186/1741-7015-4-11.

Additional files

Editorial Notes