Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B

Phase 3

Completed

• Conditions: Pain; Analgesia
• Interventions: Procedure: Water 2mL PO 2 minutes prior to intra-muscular injection; Procedure: neonates will receive skin-to-skin contact beginning 2 minutes after the intra-muscular injection and stopping 2 minutes afterwards.; Procedure: skin-to-skin contact; Procedure: Glucose 25% 2 mL PO 2 minutes prior to injection

• 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

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2007-10
• Status Verified: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2008-07-10
• Study First Submitted QC: 2008-07-11
• Last Update Submitted: 2008-07-11
• Study First Posted: 2008-07-14
• Last Update Posted: 2008-07-14

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

Arm && Interventions

Group	Intervention	Description
Noanalgesia	Water 2mL PO 2 minutes prior to intra-muscular injection	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.
Skin&Glucose	neonates will receive skin-to-skin contact beginning 2 minutes after the intra-muscular injection and stopping 2 minutes afterwards.	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.
Skin-to-skin	skin-to-skin contact	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.
Glucose	Glucose 25% 2 mL PO 2 minutes prior to injection	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.

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