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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713986
• Other study ID #: ID: AGC 1107
• Status: Completed
• Phase: Phase 3
• First received: July 10, 2008
• Last updated: July 11, 2008
• Start date: March 2006
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: July 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 72 Hours

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesia
• Pain

Intervention

Procedure:
• Water 2mL PO 2 minutes prior to intra-muscular injection
Sterile Water 2mL PO - single dose
• skin-to-skin contact
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
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.
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No