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Non-pharmacological Analgesia During Heel Prick

This study has been terminated.
(The data showed that pain was higher for our standardized method of sampling)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01576432
First Posted: April 12, 2012
Last Update Posted: April 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Miguel Angel Marin Gabriel, Puerta de Hierro University Hospital
  Purpose

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.


Condition Intervention
Pain Breastfeeding Behavioral: Assess pain with the NIPS score

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Non-pharmacological Analgesia During Heel Prick: A Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Miguel Angel Marin Gabriel, Puerta de Hierro University Hospital:

Primary Outcome Measures:
  • NIPS score during heel prick in healthy term neonates [ Time Frame: Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months. ]

    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)



Secondary Outcome Measures:
  • Crying time during heel prick in healthy term neonates [ Time Frame: Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months. ]
    Crying time (in seconds) in 4 groups where different methods of non-pharmacological analgesia were applied. The timer was started at heel prick and stopped when 5 dried spots of blood were collected on a filter paper card. Results are shown as mean+-SD.

  • Percentage of crying during heel prick in healthy term neonates [ Time Frame: Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months. ]
    Percentage of crying in 4 groups where different methods of non-pharmacological analgesia were applied during heel prick. Percentage of crying was defined as the ratio between crying time while sampling and time of the procedure. Results are shown as mean+-SD.

  • Heart rate during heel prick in healthy term neonates [ Time Frame: Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months. ]
    Heart rate was monitored by a pulse oximeter (Radical MasimoSet Datascope, Masimo Corporation, Irvine, CA) set on the infant's hand or foot. Hear rate was measured continuously but special attention was given to three time points: t0 (2 minutes before sampling); t1 (the highest value of the first 10 seconds after heel prick); and t2 (2 minutes after the procedure). Results are shown as Mean+-SD

  • Sampling duration during heel prick in healthy term neonates [ Time Frame: Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months. ]
    Sampling duration (in seconds) was defined as the time spent to obtained 5 dried spots of blood collected on a filter paper card. Results are shown as mean+-SD.

  • Number of attempts during heel prick [ Time Frame: Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months. ]
    Number of attempts need to obtaine 5 dried spots of blood collected on a filter paper card. Results are shown as % of patients with 1 attempt and % of patients with 2 attempts.


Enrollment: 136
Study Start Date: January 2011
Study Completion Date: April 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breastfeeding + skin-to-skin contact
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
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.
Experimental: Sucrose + skin-to-skin contact
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
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.
Experimental: Skin-to-skin contact
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
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.
Active Comparator: Sucrose
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
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   37 Weeks to 41 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Maternal use of opioids.
  • Birth in general anesthesia.
  • Artificial feeding.
  • Previous capillar or venous sampling.
  • Previous admission to the neonatal unit.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576432


Locations
Spain
Hospital Universitario Puerta de Hierro-Majadahonda
Madrid, Spain, 28220
Sponsors and Collaborators
Puerta de Hierro University Hospital
Investigators
Principal Investigator: Miguel A Marín Gabriel, MD Deparment of Pediatrics. Hospital Universitario Puerta de Hierro-Majadahonda. Madrid. Spain
  More Information

Publications:
Porter FL, Wolf CM, Gold J, Lotsoff D, Miller JP. Pain and pain management in newborn infants: a survey of physicians and nurses. Pediatrics. 1997 Oct;100(4):626-32.
Perapoch López J, Pallás Alonso CR, Linde Sillo MA, Moral Pumarega MT, Benito Castro F, López Maestro M, Caserío Carbonero S, de la Cruz Bértolo J. [Developmental centered care. Evaluation of Spanish neonatal units]. An Pediatr (Barc). 2006 Feb;64(2):132-9. Spanish.
Anand KJ. Clinical importance of pain and stress in preterm neonates. Biol Neonate. 1998;73(1):1-9. Review.
Mainous RO, Looney S. A pilot study of changes in cerebral blood flow velocity, resistance, and vital signs following a painful stimulus in the premature infant. Adv Neonatal Care. 2007 Apr;7(2):88-104.
Lindh V, Wiklund U, Håkansson S. Heel lancing in term new-born infants: an evaluation of pain by frequency domain analysis of heart rate variability. Pain. 1999 Mar;80(1-2):143-8.
Grunau RE, Holsti L, Peters JW. Long-term consequences of pain in human neonates. Semin Fetal Neonatal Med. 2006 Aug;11(4):268-75. Epub 2006 Apr 24. Review.
Slater R, Cornelissen L, Fabrizi L, Patten D, Yoxen J, Worley A, Boyd S, Meek J, Fitzgerald M. Oral sucrose as an analgesic drug for procedural pain in newborn infants: a randomised controlled trial. Lancet. 2010 Oct 9;376(9748):1225-32. doi: 10.1016/S0140-6736(10)61303-7.
Marín Gabriel MA, López Escobar A, Galán Redondo M, Fernández Moreno I, del Cerro García R, Llana Martín I, de la Cruz Bértolo J, Lora Pablos D. [Evaluation of pain in a neonatal intensive care unit during endocrine-metabolic tests]. An Pediatr (Barc). 2008 Oct;69(4):316-21. Spanish. Erratum in: An Pediatr (Barc). 2010 Mar;72(3):236. Fernández Bule, I [corrected to Fernández Moreno, I].
Bilgen H, Ozek E, Cebeci D, Ors R. Comparison of sucrose, expressed breast milk, and breast-feeding on the neonatal response to heel prick. J Pain. 2001 Oct;2(5):301-5. Retraction in: J Pain. 2003 Sep;4(7):415.
Retraction in: J Pain. 2003 Sep;4(7):415
Hartling L, Shaik MS, Tjosvold L, Leicht R, Liang Y, Kumar M. Music for medical indications in the neonatal period: a systematic review of randomised controlled trials. Arch Dis Child Fetal Neonatal Ed. 2009 Sep;94(5):F349-54. doi: 10.1136/adc.2008.148411. Epub 2009 May 28. Review.
Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.
Stevens B, Johnston C, Petryshen P, Taddio A. Premature Infant Pain Profile: development and initial validation. Clin J Pain. 1996 Mar;12(1):13-22.
Anand KJ; International Evidence-Based Group for Neonatal Pain. Consensus statement for the prevention and management of pain in the newborn. Arch Pediatr Adolesc Med. 2001 Feb;155(2):173-80. Review.
Overgaard C, Knudsen A. Pain-relieving effect of sucrose in newborns during heel prick. Biol Neonate. 1999 May;75(5):279-84.
Leslie A, Marlow N. Non-pharmacological pain relief. Semin Fetal Neonatal Med. 2006 Aug;11(4):246-50. Epub 2006 Apr 24. Review.
Bellieni CV, Bagnoli F, Perrone S, Nenci A, Cordelli DM, Fusi M, Ceccarelli S, Buonocore G. Effect of multisensory stimulation on analgesia in term neonates: a randomized controlled trial. Pediatr Res. 2002 Apr;51(4):460-3.
Gibbins S, Stevens B. Mechanisms of sucrose and non-nutritive sucking in procedural pain management in infants. Pain Res Manag. 2001 Spring;6(1):21-8. Review.
Gradin M, Schollin J. The role of endogenous opioids in mediating pain reduction by orally administered glucose among newborns. Pediatrics. 2005 Apr;115(4):1004-7.
Gray L, Miller LW, Philipp BL, Blass EM. Breastfeeding is analgesic in healthy newborns. Pediatrics. 2002 Apr;109(4):590-3.
Codipietro L, Ceccarelli M, Ponzone A. Breastfeeding or oral sucrose solution in term neonates receiving heel lance: a randomized, controlled trial. Pediatrics. 2008 Sep;122(3):e716-21. doi: 10.1542/peds.2008-0221.
Carbajal R, Veerapen S, Couderc S, Jugie M, Ville Y. Analgesic effect of breast feeding in term neonates: randomised controlled trial. BMJ. 2003 Jan 4;326(7379):13.
Upadhyay A, Aggarwal R, Narayan S, Joshi M, Paul VK, Deorari AK. Analgesic effect of expressed breast milk in procedural pain in term neonates: a randomized, placebo-controlled, double-blind trial. Acta Paediatr. 2004 Apr;93(4):518-22.
Castral TC, Warnock F, Leite AM, Haas VJ, Scochi CG. The effects of skin-to-skin contact during acute pain in preterm newborns. Eur J Pain. 2008 May;12(4):464-71. Epub 2007 Sep 14.
Johnston CC, Stevens B, Pinelli J, Gibbins S, Filion F, Jack A, Steele S, Boyer K, Veilleux A. Kangaroo care is effective in diminishing pain response in preterm neonates. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1084-8.
Gray L, Watt L, Blass EM. Skin-to-skin contact is analgesic in healthy newborns. Pediatrics. 2000 Jan;105(1):e14.
Okan F, Ozdil A, Bulbul A, Yapici Z, Nuhoglu A. Analgesic effects of skin-to-skin contact and breastfeeding in procedural pain in healthy term neonates. Ann Trop Paediatr. 2010;30(2):119-28. doi: 10.1179/146532810X12703902516121.
Ludington-Hoe SM, Swinth JY. Developmental aspects of kangaroo care. J Obstet Gynecol Neonatal Nurs. 1996 Oct;25(8):691-703. Review.
Weller A, Feldman R. Emotion regulation and touch in infants: the role of cholecystokinin and opioids. Peptides. 2003 May;24(5):779-88. Review.
Weller A, Blass EM. Behavioral evidence for cholecystokinin-opiate interactions in neonatal rats. Am J Physiol. 1988 Dec;255(6 Pt 2):R901-7.
Blass EM. Behavioral and physiological consequences of suckling in rat and human newborns. Acta Paediatr Suppl. 1994 Jun;397:71-6. Review.

Responsible Party: Miguel Angel Marin Gabriel, Medical Doctor, Pediatrician, Principal Investigator., Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT01576432     History of Changes
Other Study ID Numbers: 260 271110
First Submitted: April 2, 2012
First Posted: April 12, 2012
Last Update Posted: April 12, 2012
Last Verified: April 2012

Keywords provided by Miguel Angel Marin Gabriel, Puerta de Hierro University Hospital:
Pain
Breastfeeding
Heel prick
Sucrose
Skin-to-skin contact
Newborn


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