Non-pharmacological Analgesic Effects on Term Newborns

Pain Clinical Trial

Official title:

Comparing the Analgesic Effects of Four Non-pharmacological Interventions on Term Newborns Undergoing Heel Lance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03421158
• Other study ID #: 31216
• Status: Completed
• Phase: N/A
• First received: January 29, 2018
• Last updated: January 29, 2018
• Start date: November 7, 2014
• Est. completion date: August 31, 2017

Study information

• Verified date: December 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the analgesic effects of four non-pharmacological interventions: skin-to-skin contact, breastfeeding, oral sucrose and nonnutritive sucking in newborns receiving a heel lance procedure.

Description:

This is an randomized control clinical study. study population is healthy term newborns.Patients were identified by chart review and consent was received by nurse researcher. Newborns were randomized into either the control group who received no pain intervention or the intervention group who received one of four non-pharmacological pain interventions: skin to skin contact, breastfeeding, oral sucrose, and nonnutritive sucking.

A heel lance for newborn screen blood sampling was selected as a study procedure and performed by a hospital technician following standard protocol. Pain scoring was assessed by two research nurses after the hell lance and through the procedure. Neonatal Pain, Agitation and Sedation Scale (NPASS) was selected as a pain assessment tool for this study.

The average pain score from two research nurses were used for statistical analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: August 31, 2017
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 48 Hours

Eligibility

Inclusion Criteria:

• Gestational Age 38-40

• 2.5-4.0kg

• 24-48hours of age

• Receiving heel lance procedure

• Apgar>7 at birth

• NPASS<3 at time of heel lance

Exclusion Criteria:

• Prior heel lance procedure

• birth trauma

• forceps or vacuum delivery

• maternal drug abuse during delivery

Related Conditions & MeSH terms

• Breast Feeding
• Pain

Intervention

Behavioral:
• breastfeeding
Newborns were breastfed during the procedure

Dietary Supplement:
• oral sucrose
Newborns were given oral sucrose during the procedure

Behavioral:
• Skin-to-Skin contact
Newborns were placed in direct contact with their mothers during the procedure
• Non-nutritive sucking
newborns were given a pacifier to suck on during the procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in Neonatal Pain, Agitation and Sedation Scale (NPASS) scores for newborns receiving non-pharmacologic interventions	Neonatal Pain, Agitation and Sedation Scale (NPASS) measures both behavioral and physiological components of pain by evaluating five key elements, and scores pain from 0-10 (Patricia A. Hummel, 2004). The assessment criteria are crying irritability, behavior state, facial expression, extremities tone, and vital signs.	12 month