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

Federal University of São Paulo0 sites640 target enrollmentMarch 2006

ConditionsPain Analgesia

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Pain
Sponsor: Federal University of São Paulo
Enrollment: 640
Primary Endpoint: Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP)
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

July 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Federal University of São Paulo

Eligibility Criteria

Inclusion Criteria

•Written informed consent.
•Gestational age of 37 0/7 to 41 6/7 weeks.
•Patients cared in rooming-in, with post-natal age of 12 to 72 hours of life.
•Adequate for gestational age and healthy infants.
•No other painful stimuli before study except for Vitamine K injection soon after birth.
•Interval from last feeding between 30 and 60 minutes.

Exclusion Criteria

•Mothers that used opioid at gestation labor or birth.
•Delivery under general anesthesia.
•Apgar score less than seven in the 1st or 5th minute of life.
•Neonates that received any venous, arterial, capillary or spinal puncture.
•Any congenital malformation or CNS abnormality.

Outcomes

Primary Outcomes

Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP)

Time Frame: before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection

Secondary Outcomes

Physiologic pain assessment variables: heart rate and oxygen saturation(before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection)