Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B
1 other identifier
interventional
640
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pain
Started Mar 2006
Typical duration for phase_3 pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 10, 2008
CompletedFirst Posted
Study publicly available on registry
July 14, 2008
CompletedJuly 14, 2008
July 1, 2008
1.6 years
July 10, 2008
July 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (4)
Noanalgesia
SHAM COMPARATORPatients 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.
Skin-to-skin
EXPERIMENTALPatients 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.
Glucose
EXPERIMENTALPatients 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.
Skin&Glucose
EXPERIMENTALPatients 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.
Interventions
Sterile Water 2mL PO - single dose
neonates will receive skin-to-skin contact beginning 2 minutes before 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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 19948613DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aurimery G Chermont
Federal University of Para and Federal University of São Paulo
- STUDY DIRECTOR
Ruth Guinsburg
Federal University of São Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 10, 2008
First Posted
July 14, 2008
Study Start
March 1, 2006
Primary Completion
October 1, 2007
Study Completion
July 1, 2008
Last Updated
July 14, 2008
Record last verified: 2008-07