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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pain, Analgesia

Intervention / Treatment
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* 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.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Hours
Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Noanalgesia<br>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<br>* Sterile Water 2mL PO - single dose<br>|
| Experimental: Skin-to-skin<br>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<br>* neonates will receive skin-to-skin contact beginning 2 minutes before the intra-muscular injection and stopping 2 minutes afterwards.<br>|
| Experimental: Glucose<br>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<br>* Glucose 25% 2mL PO - single dose<br>|
| Experimental: Skin&Glucose<br>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.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Newborn Infant, Analgesia