How effective is Ametop 4% gel, before a venipuncture, at reducing procedural pain in infants: a randomized placebo-controlled trial

ISRCTN	ISRCTN42842643
DOI	https://doi.org/10.1186/ISRCTN42842643
Protocol serial number	BL 002
Sponsor	Children's Hospital of Eastern Ontario Research Institute (Canada)
Funder	Physicians Services Incorporated (#02-39) and Children's Hospital of Eastern Ontario Research Institute

Submission date: 29/07/2005
Registration date: 04/11/2005
Last edited: 27/10/2022

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

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 controlled trial
Secondary study design	Randomised controlled trial
Scientific title	How effective is Ametop 4% gel, before a venipuncture, at reducing procedural pain in infants: a randomized placebo-controlled trial
Study objectives	Amethocaine 4% gel applied before a venipuncture in newborn infants will safely and significantly decrease procedural pain
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Ametop (amethocaine, tetracaine hydrochloride) 4% gel
Primary outcome measure(s)	Premature Infant Pain Profile (PIPP) score in the first minute after skin puncture
Key secondary outcome measure(s)	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.
Completion date	30/12/2004

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	54
Total final enrolment	142
Key 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
Key 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)
Date of first enrolment	03/01/2003
Date of final enrolment	30/12/2004

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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		08/02/2007	27/10/2022	Yes	No

Editorial Notes

27/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.