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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:
ClinicalTrials.gov Identifier:
NCT00713986
First Posted: July 14, 2008
Last Update Posted: July 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

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 ]

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

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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: July 10, 2008
First Posted: July 14, 2008
Last Update Posted: July 14, 2008
Last Verified: July 2008

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

Additional relevant MeSH terms:
Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Vaccines
Tin Fluorides
Immunologic Factors
Physiological Effects of Drugs
Cariostatic Agents
Protective Agents