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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN75884221

Enrollment

Registered

2005-11-18

Start date

2002-12-18

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Procedural pain in premature infants Neonatal Diseases Procedural pain

Interventions

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 bef

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Premature Infant Pain Profile (PIPP) score at 1 minute	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026