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

Completed

Conditions: Procedural pain in premature infants
Neonatal Diseases
Procedural pain

Registration Number: ISRCTN75884221

Lead Sponsor: Children?s Hospital of Eastern Ontario Research Institute (CHEORI) (Canada)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 54

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Premature Infant Pain Profile (PIPP) score at 1 minute

Secondary Outcome Measures

Name	Time	Method
1. PIPP scores at 1, 2, 3 and 4 minutes after the PICC<br>2. Physiological indicators of pain (HR, Sa02, BP, RR) at 1, 2, 3, 4, 5 and 10 minutes<br>3. Duration of cry in seconds from PICC insertion to recovery, number of attempts and success rate at inserting the PICC. <br>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