Status:
COMPLETED
Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B
Lead Sponsor:
Federal University of São Paulo
Conditions:
Pain
Analgesia
Eligibility:
All Genders
12-72 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
640 Patients enrolled
Trial Details
Trial ID
NCT00713986
Start Date
March 1 2006
End Date
July 1 2008
Last Update
July 14 2008
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