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

PHASE3CompletedINTERVENTIONAL
Enrollment

640

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

October 31, 2007

Study Completion Date

July 31, 2008

Conditions
PainAnalgesia
Interventions
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.

All Listed Sponsors
lead

Federal University of São Paulo

OTHER

NCT00713986 - Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B | Biotech Hunter | Biotech Hunter