Minimizing needle poke pain in newborn infants with a pain relieving cream and sugar water

Completed

• Conditions: ewborns undergoing painful procedure; Signs and Symptoms; Infant pain

• Registration Number: ISRCTN82181559
• Lead Sponsor: The Hospital for Sick Children (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

All healthy full-term (greater than 37 weeks gestational age) newborn infants (either sex)

Exclusion Criteria

1. Neonatal Intensive Care Unit (NICU) admission
2. Asphyxia, seizures
3. Major birth defects (heart, brain, genetic syndrome)
4. Circumcised during study
5. Receiving analgesia/sedatives

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infant pain during venipuncture as assessed by facial grimacing response - the score will incorporate three facial actions: brow bulge, eye squeezed shut, naso-labial furrow, during venipuncture.

Secondary Outcome Measures

Name	Time	Method
1. Visual Analog Scale (VAS), during venipuncture<br>2. Cry duration, during venipuncture<br>3. Heart rate, during venipuncture<br>4. Number of attempts until procedure completion, from first needle poke to completion<br>5. Endomorphins -1, -2, levels, before and 10 minutes after sucrose/sucrose placebo administration<br>6. Procedure duration, from first needle poke to completion<br>7. Lidocaine levels, 5 - 15 minutes after the liposomal lidocaine cream/placebo cream is removed