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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00713986

Enrollment

640

Registered

2008-07-14

Start date

2006-03-31

Completion date

2008-07-31

Last updated

2008-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Analgesia

Keywords

Pain, Newborn Infant, Analgesia

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.

Interventions

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

Sterile Water 2mL PO - single dose

PROCEDUREskin-to-skin contact

neonates will receive skin-to-skin contact beginning 2 minutes before the intra-muscular injection and stopping 2 minutes afterwards.

PROCEDUREGlucose 25% 2 mL PO 2 minutes prior to injection

Glucose 25% 2mL PO - single dose

PROCEDUREneonates 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Hours to 72 Hours

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.

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026