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

Primary Purpose

Pain, Analgesia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Water 2mL PO 2 minutes prior to intra-muscular injection
skin-to-skin contact
Glucose 25% 2 mL PO 2 minutes prior to injection
neonates will receive skin-to-skin contact beginning 2 minutes after the intra-muscular injection and stopping 2 minutes afterwards.
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Newborn Infant, Analgesia

Eligibility Criteria

12 Hours - 72 Hours (Child)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Sham Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Noanalgesia

    Skin-to-skin

    Glucose

    Skin&Glucose

    Arm 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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP)

    Secondary Outcome Measures

    Physiologic pain assessment variables: heart rate and oxygen saturation

    Full Information

    First Posted
    July 10, 2008
    Last Updated
    July 11, 2008
    Sponsor
    Federal University of São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00713986
    Brief Title
    Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2006 (undefined)
    Primary Completion Date
    October 2007 (Actual)
    Study Completion Date
    July 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Federal University of São Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Analgesia
    Keywords
    Pain, Newborn Infant, Analgesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    640 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Noanalgesia
    Arm Type
    Sham Comparator
    Arm 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.
    Arm Title
    Skin-to-skin
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Glucose
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Skin&Glucose
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Water 2mL PO 2 minutes prior to intra-muscular injection
    Intervention Description
    Sterile Water 2mL PO - single dose
    Intervention Type
    Procedure
    Intervention Name(s)
    skin-to-skin contact
    Intervention Description
    neonates will receive skin-to-skin contact beginning 2 minutes before the intra-muscular injection and stopping 2 minutes afterwards.
    Intervention Type
    Procedure
    Intervention Name(s)
    Glucose 25% 2 mL PO 2 minutes prior to injection
    Intervention Description
    Glucose 25% 2mL PO - single dose
    Intervention Type
    Procedure
    Intervention Name(s)
    neonates will receive skin-to-skin contact beginning 2 minutes after the intra-muscular injection and stopping 2 minutes afterwards.
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Hours
    Maximum Age & Unit of Time
    72 Hours
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aurimery G Chermont
    Organizational Affiliation
    Federal University of Para and Federal University of São Paulo
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ruth Guinsburg
    Organizational Affiliation
    Federal University of São Paulo
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19948613
    Citation
    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.
    Results Reference
    derived

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

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