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The objective of this trial is to compare the analgesic effect of a single dose of oral sucrose 24% administered two minutes before a blood sampling (either heel prick or vascular puncture) versus multiple doses of oral sucrose 24% administered two minutes before and during the procedure in a population of preterm newborns of Gestational Age ≤ 36+6 weeks hospitalized in Neonatal Intensive Care Unit, using neonatal pain scales (Premature Infant Pain Profile (PIPP), Face, Legs, Activity, Cry, Consolability (FLACC) and indirect Visual Analogue Scale (VAS)) and Skin Conductance (SC) measurement (Pain Monitor).
This is a controlled, randomized, double blind, (double--dummy) study to evaluate the analgesic efficacy of sucrose. The study staff will evaluate all inborn newborns admitted to the Neonatal Intensive Care Unit (NICU) with a Gestational Age (GA) ≤36+6 weeks; the newborns will be immediately screened for eligibility based upon the pre--defined study inclusion/exclusion criteria.
Then, the parents will be informed about the study and the written informed consent form will be signed. Those eligible will be randomized into the study through computer generated randomization list.
The population of the study consists of premature infants undergoing blood sampling. It is estimated that approximately 144 premature neonates (72 per group either heel prick or venepuncture) will be included in the randomized study.
All eligible neonates whose parents have agreed to participate in the study by signing the informed consent form will be randomized as soon as they are admitted to the NICU.
This study will be conducted in 3 phases:
Algometric measurements: The pain evaluation will be done visualizing the video of the procedure. Two different evaluators independently will assign the pain score with:
Instrumental PAIN examinations: Pain Monitor is an instrument that measures SC. It detects hand or foot skin conductance gradient, which is directly related to the painful stimuli. The sympathetic nervous system releases acetylcholine that acts on muscarine receptors inducing a sweating and SC increase in response to painful stimuli. Pain monitor is simple to use: tree electrodes positioned on neonate foot sole are connected to the central system. Pain monitor immediately and continuously reacts to stimuli without being influenced neither by hemodynamic variability nor by neuromuscular blocks. The measurement its represented on a compatible computer monitor through a graphic function with SC values expressed in microsiemens on the ordinate axis and time on the abscissa axis. Stressful and painful stimuli related SC variability is represented by peaks and the under peaks area defines pain intensity at detection moment. During monitoring you can note down directly on the graphic every intervention on the patient (medication, blood sample, ect.). Detection can be extrapolated with Excel for statistical analysis.
- Follow--up phase: it will begin from the end of the blood samples. Assessments will continue until hospital discharge.
AE that are ongoing during the study phase as well as clinical outcomes (that are major clinical diagnoses) will be assessed until hospital discharge. Clinical data will be recorded on CRF. In addition the following information will be collected at hospital discharge:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sucrose24% 2 minutes before | Active Comparator | sucrose 24% 0,3 mL if < 1000 g or 0,5 mL if > 1000 g two minutes BEFORE the skin breaking procedure |
|
| sucrose24% 2minutes before and during | Experimental | sucrose 24% 0,3 mL if < 1000 g or 0,5 mL if > 1000 g two minutes BEFORE and DURING the skin breaking procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sucrose 24% | Dietary Supplement | Premature neonates undergoing blood samples through skin breaking procedures, meeting inclusion criteria, will be randomized as soon as the doctor decision to drown the blood is made, to either sucrose 24% 0,3 mL if < 1000 g or 0,5 mL if > 1000 g two minutes BEFORE the skin breaking procedure or sucrose 24% 0,3 mL if < 1000 g or 0,5 mL if > 1000 g two minutes BEFORE and DURING the skin breaking procedure, according to a computer generated randomization list. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of analgesic efficacy Premature Infant Pain Profile (PIPP) | The primary outcome of this study will be to evaluate the analgesic efficacy of sucrose 24% administration (single versus multiple doses) during blood sampling using Premature Infant Pain Profile (PIPP). | 2 minutes before, at the moment of the skin puncture, and at 30, 60 and 120 seconds after the skin puncture |
| Measure | Description | Time Frame |
|---|---|---|
| Change of analgesic efficacy Face, Legs, Activity, Cry, Consolability (FLACC) | The analgesic efficacy of sucrose 24% administration (single Vs multiple doses) during blood sampling using Face, Legs, Activity, Cry, Consolability (FLACC) | at 30 and 120 seconds after the skin puncture |
| Change of analgesic efficacy Visual Analogue Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teresa Mion, MD | Contact | +39 049 8213547 | tritrimi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Paola Lago, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Padova | Recruiting | Padova | Padova | 35128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22232305 | Background | Cignacco EL, Sellam G, Stoffel L, Gerull R, Nelle M, Anand KJ, Engberg S. Oral sucrose and "facilitated tucking" for repeated pain relief in preterms: a randomized controlled trial. Pediatrics. 2012 Feb;129(2):299-308. doi: 10.1542/peds.2011-1879. Epub 2012 Jan 9. | |
| 23235618 | Background | Shah PS, Herbozo C, Aliwalas LL, Shah VS. Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD004950. doi: 10.1002/14651858.CD004950.pub3. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
The analgesic efficacy of sucrose 24% administration (single Vs multiple doses) during blood sampling using indirect Visual Analogue Scale (VAS). |
| at 30 and 120 seconds after the skin puncture |
| Change of analgesic efficacy Pain Monitor (skin electrical conductance) | The analgesic efficacy of sucrose 24% administration (single Vs multiple doses) during blood sampling using Pain Monitor (skin electrical conductance) | 2 minutes before, at the moment of the skin puncture, and at 30, 60 and 120 seconds after the skin puncture |
| Pain evaluation during heel prick Vs vascular puncture PIPP | Pain evaluation during heel prick Vs vascular puncture will be performed using PIPP scale | Through study completion, an average of 1 year |
| Pain evaluation during heel prick Vs vascular puncture FLACC | Pain evaluation during heel prick Vs vascular puncture will be performed using FLACC scale | Through study completion, an average of 1 year |
| Pain evaluation during heel prick Vs vascular puncture VAS | Pain evaluation during heel prick Vs vascular puncture will be performed using VAS scale | Through study completion, an average of 1 year |
| Pain evaluation during heel prick Vs vascular puncture Pain Monitor (skin electrical conductance) | Pain evaluation during heel prick Vs vascular puncture will be performed using Pain Monitor (skin electrical conductance) | Through study completion, an average of 1 year |
| Intra--hospital outcome Mechanical Ventilation (MV) duration | Intra--hospital outcome MV duration | Through study completion, an average of 1 year |
| Intra--hospital outcome non-Invasive MV (nIMV) duration | Intra--hospital outcome nIMV duration | Through study completion, an average of 1 year |
| Intra--hospital outcome oxygen dependence duration | Intra--hospital outcome oxygen dependence | Through study completion, an average of 1 year |
| Intra--hospital outcome rate of Bronchopulmonary Dysplasia (BPD) | Intra--hospital outcome rate of BPD | Through study completion, an average of 1 year |
| Intra--hospital outcome rate of Pneumothorax (PNX) | Intra--hospital outcome rate of PNX | Through study completion, an average of 1 year |
| Intra--hospital outcome rate of Patent ductus arteriosus (PDA) | Intra--hospital outcome rate of PDA | Through study completion, an average of 1 year |
| Intra--hospital outcome incidence Intraventricular hemorrhage (IVH)/ Periventricular leukomalacia (PVL) | Intra--hospital outcome incidence of IVH/PVL | Through study completion, an average of 1 year |
| Intra--hospital outcome incidence death within 28 days of life | Intra--hospital outcome incidence of death within 28 days of life | within 28 days of life |
| Intra--hospital outcome incidence hydrocephalus | Intra--hospital outcome incidence of hydrocephalus | Through study completion, an average of 1 year |
| Intra--hospital outcome time to Full Enteral Feeding (FEF) | Intra--hospital outcome time to FEF | Through study completion, an average of 1 year |
| Intra--hospital outcome rate of Necrotizing Enterocolitis (NEC) | Intra--hospital outcome rate of NEC (all stages according to the modified Bell's criteria) | Through study completion, an average of 1 year |
| Intra--hospital outcome rate of proved sepsis | Intra--hospital outcome rate of proved sepsis | Through study completion, an average of 1 year |
| Intra--hospital outcome rate of suspected sepsis | Intra--hospital outcome rate of suspected sepsis | Through study completion, an average of 1 year |
| Intra--hospital outcome rate of Retinopathy of Prematurity (ROP) | Intra--hospital outcome rate of ROP | Through study completion, an average of 1 year |
| Intra--hospital outcome time to regain birth weight | Intra--hospital outcome time to regain birth weight | Through study completion, an average of 1 year |
| Intra--hospital outcome hospitalization length | Intra--hospital outcome hospitalization length | Through study completion, an average of 1 year |
| Intra--hospital outcome incidence hospital discharge without major morbidities | Intra--hospital outcome incidence of hospital discharge without major morbidities | Through study completion, an average of 1 year |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Safety [achieved by monitoring and registering adverse events (AEs), serious adverse events (SAEs) even those unexpected (SUSARs), and measuring vital signs] | Through study completion till patient discharge, an average of 1 year |
| 22392168 | Background | Simonse E, Mulder PG, van Beek RH. Analgesic effect of breast milk versus sucrose for analgesia during heel lance in late preterm infants. Pediatrics. 2012 Apr;129(4):657-63. doi: 10.1542/peds.2011-2173. Epub 2012 Mar 5. |
| 25939641 | Background | Yin T, Yang L, Lee TY, Li CC, Hua YM, Liaw JJ. Development of atraumatic heel-stick procedures by combined treatment with non-nutritive sucking, oral sucrose, and facilitated tucking: a randomised, controlled trial. Int J Nurs Stud. 2015 Aug;52(8):1288-99. doi: 10.1016/j.ijnurstu.2015.04.012. Epub 2015 Apr 23. |
| 21975734 | Background | Shah VS, Ohlsson A. Venepuncture versus heel lance for blood sampling in term neonates. Cochrane Database Syst Rev. 2011 Oct 5;2011(10):CD001452. doi: 10.1002/14651858.CD001452.pub4. |
| 23440783 | Background | Stevens B, Yamada J, Lee GY, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD001069. doi: 10.1002/14651858.CD001069.pub4. |