Two Methods of Analgesia for Chinese Term Infants Receiving Heel Lance

NCT01355640 | Completed DMC

• 1 other identifier: S2006471
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

• breast-feeding group
• non-nutritive sucking group
• control group
• The results showed that:
• Breast-feeding can reduce crying and grimace time, increase oxygen saturation.
• Non-nutritive sucking can delay grimace's starting time, increase oxygen saturation.

Conditions

Heel Pain Syndrome

Keywords

heel lance; pain; newborn

Outcome Measures

Primary Outcomes (1)

• changes in heart rate value and oxygen saturation value,time length of grimacing and crying

  1 minute before heel lance and 8 minutes after heel lance, the duration of facial grimacing and crying, heart rate and oxygen saturation values at every 15 seconds.Time length of heart rate, oxygen saturation returned to baseline values

Study Arms (3)

breast-feeding group

EXPERIMENTAL

Mothers console their babies by breast-feeding during heel lance.

Other: breast-feeding

non-nutritive sucking

EXPERIMENTAL

Every mother was given a vacuum pacifier( the brand is "Goodbaby") to console her baby during heel lance.

Other: non-nutritive sucking

control group

NO INTERVENTION

A research nurse also explained the study to the control group parents. Standard clinic procedure for infant injection was also implemented. Mothers in control group also lay on the side of the bed comfortably with their infants in their arms after the infants' soiled diapers were changed.

Interventions

breast-feeding OTHER

Mothers lay on the side of the bed comfortably with their infants in their arms after the infants' soiled diapers were changed. Mothers breast-fed their babies. The study was initiated when the infants were observed to have a large amount of areola in their mouth, with flanged lips and active jaw movements. Then two minutes after the breast-feeding, an experienced technician began to do heel lance, heel lance was given by the same experienced technician.Mothers breast-fed their babies two minutes before, during and eight minutes after the heel lance. Throughout the whole procedure, mothers were encouraged to continue breast-feeding when the babies stopped sucking and/or began to cry.

Also known as: non-pharmacological intervention

breast-feeding group

non-nutritive sucking OTHER

Mothers lay on the side of the bed comfortably with their infants in their arms after the infants' soiled diapers were changed. Each mother in this group was given a vacuum pacifier( the brand is "Goodbaby") to console her baby. Heel lance was given by the same experienced technician. The study was initiated when the infants can suck the pacifier and hold it by himself without others' help. This generally requires half or one minute. Then two minutes after non-nutritive sucking, an experienced technician began to do heel lance. Babies sucked the pacifier two minutes before, during and eight minutes after heel lance. Throughout the whole procedure, mothers were encouraged to continue non-nutritive sucking when the babies stopped sucking and/or began to cry.

Also known as: non-pharmacological intervention

non-nutritive sucking

Eligibility Criteria

• Age: 72 Hours+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infants were considered to be eligible if they have been three days old who need to receive heel lance for blood sampling test for phenylketonuria (PKU), hyperbilirubinemia, thyroid hypofunction.
• Parents of infants who met the research criteria were invited to participate in the study.

You may not qualify if:

• Infants were excluded if they had a concurrent illness.
• Preterm babies, and babies who have received any operation after birth.
• Infant' mother who had a fever or some illness was excluded.
• Infants for whom an informed parental consent could not be obtained were also excluded.
• During the heel lance, the infants who need to receive two heel lances were also excluded.

Sponsors & Collaborators

• Peking Union Medical College: lead

MeSH Terms

Conditions

Pain

Interventions

Lactation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Officials

• Jingli Chen, Master

  Peking Union Medical College

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 18, 2011
• Study Start: April 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: May 1, 2009
• Last Updated: January 31, 2012

Record last verified: 2012-01