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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
640
Sterile Water 2mL PO - single dose
neonates will receive skin-to-skin contact beginning 2 minutes before the intra-muscular injection and stopping 2 minutes afterwards.
Glucose 25% 2mL PO - single dose
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
Physiologic pain assessment variables: heart rate and oxygen saturation
Time frame: before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.