Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B
NCT ID: NCT00713986
Last Updated: 2008-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
640 participants
INTERVENTIONAL
2006-03-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Water 2mL PO 2 minutes prior to intra-muscular injection
Sterile Water 2mL PO - single dose
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.
skin-to-skin contact
neonates will receive skin-to-skin contact beginning 2 minutes before the intra-muscular injection and stopping 2 minutes afterwards.
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.
Glucose 25% 2 mL PO 2 minutes prior to injection
Glucose 25% 2mL PO - single dose
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.
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.
Interventions
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Water 2mL PO 2 minutes prior to intra-muscular injection
Sterile Water 2mL PO - single dose
skin-to-skin contact
neonates will receive skin-to-skin contact beginning 2 minutes before the intra-muscular injection and stopping 2 minutes afterwards.
Glucose 25% 2 mL PO 2 minutes prior to injection
Glucose 25% 2mL PO - single dose
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Hours
72 Hours
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Federal University of São Paulo
Principal Investigators
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Aurimery G Chermont
Role: PRINCIPAL_INVESTIGATOR
Federal University of Para and Federal University of São Paulo
Ruth Guinsburg
Role: STUDY_DIRECTOR
Federal University of São Paulo
References
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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.
Other Identifiers
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ID: AGC 1107
Identifier Type: -
Identifier Source: org_study_id