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

Federal University of São Paulo

Status and phase: Completed; Phase 3

Conditions: Analgesia; Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00713986

ID: AGC 1107

Details and patient eligibility

About

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.

Enrollment: 640 patients

Sex: All

Ages: 12 to 72 hours old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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640 participants in 4 patient groups

Noanalgesia

Sham Comparator group

Description:

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.

Treatment:

Procedure: Water 2mL PO 2 minutes prior to intra-muscular injection

Skin-to-skin

Experimental group

Description:

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.

Treatment:

Procedure: skin-to-skin contact

Glucose

Experimental group

Description:

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.

Treatment:

Procedure: Glucose 25% 2 mL PO 2 minutes prior to injection

Skin&Glucose

Experimental group

Description:

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.

Treatment:

Procedure: neonates will receive skin-to-skin contact beginning 2 minutes after the intra-muscular injection and stopping 2 minutes afterwards.