4% Ametop gel to reduce procedural pain in infants receiving a percutaneously inserted central catheter (PICC)

ISRCTN	ISRCTN75884221
DOI	https://doi.org/10.1186/ISRCTN75884221
Protocol serial number	FRN: 59754
Sponsor	Childrens Hospital of Eastern Ontario Research Institute (CHEORI) (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: FRN: 59754)

Submission date: 18/11/2005
Registration date: 18/11/2005
Last edited: 06/03/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Brigitte Lemyre
Scientific

401 Smyth Road
Ottawa
K1H 8L1
Canada

Email	blemyre@ottawahospital.on.ca

Study information

Primary study design	Interventional
Study design	Randomised placebo controlled trial
Secondary study design	Randomised controlled trial
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
Study objectives	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(s)	The Ottawa Hospital Research Ethics Board gave approval on the 27th June 2002.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Ametop
Primary outcome measure(s)	Premature Infant Pain Profile (PIPP) score at 1 minute
Key secondary outcome measure(s)	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
Completion date	26/07/2004

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	54
Key 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
Key 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
Date of first enrolment	18/12/2002
Date of final enrolment	26/07/2004

Locations

Countries of recruitment

Canada

Study participating centre

401 Smyth Road

Ottawa
K1H 8L1
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/05/2006		Yes	No