NCT00713986

Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B

Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B: a Comparison Between Skin-to-Skin Contact, Glucose 25% and Both of Them

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 640 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 12 Hours – 72 Hours
• Healthy volunteers: Not accepted

Summary

Acute procedural pain in neonates may be alleviated by non-pharmacological procedures. This study objective is to test the efficacy regarding pain attenuation of 3 interventions (skin-to-skin contact versus glucose 25% versus skin to skin associated to glucose 25) versus control in healthy newborn infants submitted to intra-muscular vaccination for Hepatitis B at 48-72 hours of life.

Conditions

• Pain
• Analgesia

Interventions

Type	Name	Description
PROCEDURE	Water 2mL PO 2 minutes prior to intra-muscular injection	Sterile Water 2mL PO - single dose
PROCEDURE	skin-to-skin contact	neonates will receive skin-to-skin contact beginning 2 minutes before the intra-muscular injection and stopping 2 minutes afterwards.
PROCEDURE	Glucose 25% 2 mL PO 2 minutes prior to injection	Glucose 25% 2mL PO - single dose
PROCEDURE	neonates will receive skin-to-skin contact beginning 2 minutes after the intra-muscular injection and stopping 2 minutes afterwards.	neonates will receive 2 mL of glucose 25% PO (single dose) 2 minutes prior to the acute painful procedure. Skin-to-skin contact will start 2 minutes after the intra-muscular injection and will stop 2 minutes afterwards.

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-10-01
• Completion: 2008-07-01
• First posted: 2008-07-14
• Last updated: 2008-07-14