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

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00713986
First received: July 10, 2008
Last updated: July 11, 2008
Last verified: July 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain
Analgesia
 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.
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP) [ Time Frame: before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physiologic pain assessment variables: heart rate and oxygen saturation [ Time Frame: before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection ] [ Designated as safety issue: No ]

Enrollment: 640
Study Start Date: March 2006
Study Completion Date: July 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713986

Sponsors and Collaborators
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
  More Information

No publications provided by Federal University of São Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ruth Guinsburg, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00713986     History of Changes
Other Study ID Numbers: ID: AGC 1107
Study First Received: July 10, 2008
Last Updated: July 11, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Pain
Newborn Infant
Analgesia

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on May 22, 2013