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

Not Applicable

Completed

• Conditions: Procedural pain; Signs and Symptoms; Pain

• Registration Number: ISRCTN42842643
• Lead Sponsor: Children's Hospital of Eastern Ontario Research Institute (Canada)

Brief Summary

2007 Results article in https://pubmed.ncbi.nlm.nih.gov/17288611/ (added 27/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2004-12-30
• Study Start: 2005-11-04
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 142

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified