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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN42842643

Enrollment

Registered

2005-11-04

Start date

2003-01-03

Completion date

Unknown

Last updated

2022-11-07

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

Conditions

Procedural pain Signs and Symptoms Pain

Interventions

Ametop (amethocaine) 4% gel versus placebo, 1.5 g applied to skin for 30 minutes prior to the venipuncture

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Premature Infant Pain Profile (PIPP) score in the first minute after skin puncture	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Canada

Outcome results

None listed

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