Non-pharmacological Analgesia During Heel Prick

NCT01576432 | Terminated

• 1 other identifier: 260 271110
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Objective To investigate the analgesic effect (measured with NIPS) of breastfeeding in addition to skin-to-skin contact versus other methods of non-pharmacological analgesia during blood sampling through heel lance in healthy term neonates. The influences of non-pharmacological methods on crying time, percentage of crying while sampling, heart rate, number of attempts and duration of sampling were studied. Methods Randomised controlled trial performed on 136 healthy term newborns in the maternity ward of a tertiary hospital. The inclusion criteria were: healthy term neonates, wish to breastfeed and absence of feeding during the previous 60 minutes. Neonates were randomly assigned to four groups: group 1, breastfed with skin-to-skin contact ; group 2, oral sucrose with skin-to-skin contact ; group 3, skin-to-skin contact ; or group 4, receiving oral sucrose Data for the primary objective was analysed per intention to treat. This study was approved by local ethical committee.

Conditions

Pain; Breastfeeding

Keywords

Pain; Breastfeeding; Heel prick; Sucrose; Skin-to-skin contact; Newborn

Outcome Measures

Primary Outcomes (1)

• NIPS score during heel prick in healthy term neonates

  The NIPS scale is a validated 6-indicator scale for the assessment of acute pain in neonates. Score ranges from 0 (no pain) to 7 (severe pain). NIPS score was evaluated at three time points (2 minutes before heel prick (NIPS-t0), during heel prick (NIPS-t1) and 2 minutes after heel lance (NIPS-t2))in 4 groups where different methods of non-pharmacological analgesia were applied. Results are shown as mean+-SD. NIPS score ≥4 means moderate-severe pain. Thus results are also shown as the % of patients with NIPS score ≥4 at different time points (t0, t1 and t2)

  Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months.

Secondary Outcomes (5)

• Crying time during heel prick in healthy term neonates

  Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months.

• Percentage of crying during heel prick in healthy term neonates

  Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months.

• Heart rate during heel prick in healthy term neonates

  Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months.

• Sampling duration during heel prick in healthy term neonates

  Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months.

• Number of attempts during heel prick

  Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months.

Study Arms (4)

Breastfeeding + skin-to-skin contact

EXPERIMENTAL

In group 1 (BF+SSC), neonates dressed with a diaper were held in prone, in SSC with the mother; breastfeeding (BF) was started at least 5 minutes before heel lance and maintained during sampling

Behavioral: Assess pain with the NIPS score

Sucrose + skin-to-skin contact

EXPERIMENTAL

In group 2 (sucrose + SSC), neonates were held in prone between the mothers' breast at least 5 minutes before sampling and 2 ml 24% sucrose was given with a sterile syringe in the mouth 2 minutes before heel lance.

Behavioral: Assess pain with the NIPS score

Skin-to-skin contact

EXPERIMENTAL

In group 3 (SSC), neonates were held between the mother's breast as in group 2, but no sucrose was given.

Behavioral: Assess pain with the NIPS score

Sucrose

ACTIVE COMPARATOR

In group 4 (Sucrose), 2 ml 24% sucrose was administered through a sterile syringe in the mouth 2 minutes before heel lance to neonates laid on supine on a cot; the procedure was done in the presence of the mother

Behavioral: Assess pain with the NIPS score

Interventions

Assess pain with the NIPS score BEHAVIORAL

In group 1 (BF+SSC), neonates dressed with a diaper were held in prone, in SSC with the mother; BF was started at least 5 minutes before heel lance and maintained during sampling. In group 2 (sucrose + SSC), neonates were held in prone between the mothers' breast at least 5 minutes before sampling and 2 ml 24% sucrose was given with a sterile syringe in the mouth 2 minutes before heel lance. In group 3 (SSC), neonates were held between the mother's breast as in group 2, but no sucrose was given. In group 4 (Sucrose), 2 ml 24% sucrose was administered through a sterile syringe in the mouth 2 minutes before heel lance to neonates laid on supine on a cot; the procedure was done in the presence of the mother. Mothers were allowed to speak or touch their babies in all the groups.

Breastfeeding + skin-to-skin contact; Skin-to-skin contact; Sucrose; Sucrose + skin-to-skin contact

Eligibility Criteria

• Age: 37 Weeks - 41 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy term neonates (37-41+6 weeks of gestation) confirmed through a routine physical exam during the first 24h of life
• Wish to breastfeed
• Absence of feeding during the previous 60 minutes.

You may not qualify if:

• Maternal use of opioids.
• Birth in general anesthesia.
• Artificial feeding.
• Previous capillar or venous sampling.
• Previous admission to the neonatal unit.

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead

Study Sites (1)

Hospital Universitario Puerta de Hierro-Majadahonda

Madrid, Madrid, 28220, Spain

Location

Related Publications (30)

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MeSH Terms

Conditions

Pain; Breast Feeding

Condition Hierarchy (Ancestors)

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

Study Officials

• Miguel A Marín Gabriel, MD

  Deparment of Pediatrics. Hospital Universitario Puerta de Hierro-Majadahonda. Madrid. Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Pediatrician, Principal Investigator.

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 12, 2012
• Study Start: January 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 12, 2012

Record last verified: 2012-04

Locations

ES (1)