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

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT00713986

Collaborator

(none)

640

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Analgesia	Procedure: Water 2mL PO 2 minutes prior to intra-muscular injection Procedure: skin-to-skin contact Procedure: Glucose 25% 2 mL PO 2 minutes prior to injection Procedure: neonates will receive skin-to-skin contact beginning 2 minutes after the intra-muscular injection and stopping 2 minutes afterwards.	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

640 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B: a Comparison Between Skin-to-Skin Contact, Glucose 25% and Both of Them

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Noanalgesia 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.	Procedure: Water 2mL PO 2 minutes prior to intra-muscular injection Sterile Water 2mL PO - single dose
Experimental: Skin-to-skin 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.	Procedure: skin-to-skin contact neonates will receive skin-to-skin contact beginning 2 minutes before the intra-muscular injection and stopping 2 minutes afterwards.
Experimental: Glucose 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.	Procedure: Glucose 25% 2 mL PO 2 minutes prior to injection Glucose 25% 2mL PO - single dose
Experimental: Skin&Glucose 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.	Procedure: neonates will receive skin-to-skin contact beginning 2 minutes after the intra-muscular injection and stopping 2 minutes afterwards. 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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Hours to 72 Hours

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Principal Investigator: Aurimery G Chermont, Federal University of Para and Federal University of São Paulo
Study Director: Ruth Guinsburg, Federal University of São Paulo