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

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN75884221
• Date of registration: 18/11/2005
• Primary sponsor: Children?s Hospital of Eastern Ontario Research Institute (CHEORI) (Canada)
• Public title: 4% Ametop gel to reduce procedural pain in infants receiving a percutaneously inserted central catheter (PICC) N/A
• 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
• Date of first enrolment: Dec 18 2002
• Target sample size: 54
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN75884221
• Study type: Interventional
• Study design: Randomised placebo controlled trial

Countries of recruitment

Canada

Contacts

• Name: Brigitte Lemyre

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Procedural pain in premature infants

Intervention(s)

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

Primary Outcome(s)

Premature Infant Pain Profile (PIPP) score at 1 minute

Secondary Outcome(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

Secondary ID(s)

FRN: 59754

Source(s) of Monetary Support

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

Secondary Sponsor(s)

N/A