Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B
Phase 3
Completed
- Conditions
- PainAnalgesia
- Registration Number
- NCT00713986
- Lead Sponsor
- Federal University of São Paulo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 640
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP) before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection
- Secondary Outcome Measures
Name Time Method 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