Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B
Pain, Analgesia
About this trial
This is an interventional treatment trial for Pain focused on measuring Pain, Newborn Infant, Analgesia
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Sham Comparator
Experimental
Experimental
Experimental
Noanalgesia
Skin-to-skin
Glucose
Skin&Glucose
Patients in this group wil receive 2 mL of water PO 2 minutes prior to vaccination, then they will rest in crib during cleansing of the right tigh, during injection of the right tigh for hepatitis B vaccination and 2 minutes after the injection. Infants will not receive any handling during the whole procedure outside the prespecified above.
Patients in this group wil receive 2mL of water 2 minutes prior vaccination and will be put on skin-to-skin contact with their mothers at the same time. After this time cleansing of the right tigh will be done followed by intra-muscular injection for hepatitis B vaccination. Patients will stay on skin-to-skin contact with their mothers for the following 2 minutes after injection. Infants will not receive any additional sensorial stimulation during the whole procedure outside the prespecified above.
Patients in this group wil receive 2mL of glucose 25% 2 minutes prior vaccination, then they will rest in crib during cleansing of the right tigh, during injection of the right tigh for hepatitis B vaccination and 2 minutes after the injection. Infants will not receive any handling during the whole procedure outside the prespecified above.
Patients in this group wil receive 2mL of glucose 25% PO 2 minutes prior vaccination and will be put on skin-to-skin contact with their mothers at the same time. After this time cleansing of the right tigh will be done followed by intra-muscular injection for hepatitis B vaccination. Patients will stay on skin-to-skin contact with their mothers for the following 2 minutes after injection. Infants will not receive any additional sensorial stimulation during the whole procedure outside the prespecified above.