Skip to main content
OpenTrials
Completed

NCT Number: NCT00713986

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

12 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Water 2mL PO 2 minutes prior to intra-muscular injection

Procedure

Sterile Water 2mL PO - single dose

skin-to-skin contact

Procedure

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

Procedure

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.

Procedure

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 outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Jul 14, 2008
Registry last updated
Jul 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.