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| Name | Class |
|---|---|
| Agnelli Hospital, Italy | OTHER |
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The purpose of this study is to compare the antinociceptive effect of 1 ml of 30% sucrose solution vs breastfeeding on neonatal screening heel lance
Blood sampling heel lance for neonatal screening is the most frequent painful manoeuvre in Neonatal Units in healthy neonates.
Some techniques showed efficacy evidence in reducing pain response: sucrose solutions, breastfeeding during blood sampling, topical local anaesthetics.
A Cochrane Review in 2004 recommends the administration of sucrose 0.24-0.48 g (1-2 ml of 24% sucrose solution). It reduces PIPP scale rate about 20%.
Our purpose is to compare the antinociceptive effect of 1 ml 30% sucrose solution administered 2 minutes before heel lancing vs blood sampling heel lance during breastfeeding.
PIPP scale is a validated 7-indicator scale for the assessment of procedural pain in preterm and term neonates.
Informant consent was asked parents during consultation by a Pediatrician of the Neonatal Unit of the Hospital in the last months of pregnancy.
After parent written consent was obtained, 100 three day old neonates were randomized for treatment A (breastfeeding) or B (sucrose solution administration). The nurse opened consecutively numbered envelopes.
Timing of operators: Group A Breastfeeding
Group B Sucrose administration
Blood sampling was practiced by skilled pediatric nurses. Registration of data, PIPP scale, voice record was made by a second operator, blind to the pur pose of the study.
A third blind operator collected paper data and checked voice record (outcome cry behaviour).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sucrose solution 30%1 ml | Drug | |||
| Breastfeeding | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| Premature Infant Pain Profile (PIPP) scale rate (0-21) | 15 seconds before and Within 30 seconds after heel lance |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Increase | within 30 seconds after heel lance | |
| Oxygen Saturation decrease | within 30 seconds after heel lance | |
| Duration of first cry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luigi Codipietro, MD | University of Turin Department of Paediatric Science Doctorate in Experimental Pediatry | Principal Investigator |
| Alberto Ponzone, MD | University of Turin Department of Paediatric Science Doctorate in Experimental Pediatry | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agnelli Hospital ASL 10 | Pinerolo | Torino | 10064 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15266438 | Background | Stevens B, Yamada J, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2004;(3):CD001069. doi: 10.1002/14651858.CD001069.pub2. | |
| 12511452 | Background | 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. doi: 10.1136/bmj.326.7379.13. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005247 | Feeding Behavior |
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| ID | Term |
|---|---|
| D007774 | Lactation |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D049590 | Postpartum Period |
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| within 2 minutes after heel lance |
| Percentage of crying time | within 2 minutes after heel lance |
| Percentage of crying time | During blood sampling |
| 16856069 | Background | Shah PS, Aliwalas LI, Shah V. Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD004950. doi: 10.1002/14651858.CD004950.pub2. |
| 10617258 | Background | Ballantyne M, Stevens B, McAllister M, Dionne K, Jack A. Validation of the premature infant pain profile in the clinical setting. Clin J Pain. 1999 Dec;15(4):297-303. doi: 10.1097/00002508-199912000-00006. |
| 18762508 | Derived | 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. |
| D001519 | Behavior |