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

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

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 Overview

• Status: Completed
• Conditions: Pain; Analgesia
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 640
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 hours to 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Chermont AG, Falcao LF, de Souza Silva EH, de Cassia Xavier Balda R, Guinsburg R. Skin-to-skin contact and/or oral 25% dextrose for procedural pain relief for term newborn infants. Pediatrics. 2009 Dec;124(6):e1101-7. doi: 10.1542/peds.2009-0993.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: July 10, 2008
• First Submitted That Met QC Criteria: July 11, 2008
• First Posted (Estimate): July 14, 2008

Study Record Updates

• Last Update Posted (Estimate): July 14, 2008
• Last Update Submitted That Met QC Criteria: July 11, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Pain; Analgesia; Newborn Infant
• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis; Hepatitis B; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Tin Fluorides
• Other Study ID Numbers: ID: AGC 1107