An interventional study of sucrose 24% in Pain, sponsored by University Hospital Padova. Status unknown at 1 site in Italy. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2016-08-09.
Sponsored by University Hospital Padova · Not applicable, Interventional, and Prevention
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.
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:
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 144 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University Hospital Padova is the lead sponsor of 41 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
sucrose 24% 0,3 mL if \< 1000 g or 0,5 mL if \> 1000 g two minutes BEFORE the skin breaking procedure
Dietary Supplement: sucrose 24%
sucrose 24% 0,3 mL if \< 1000 g or 0,5 mL if \> 1000 g two minutes BEFORE and DURING the skin breaking procedure
Dietary Supplement: sucrose 24%
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.
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).
Time frame: 2 minutes before, at the moment of the skin puncture, and at 30, 60 and 120 seconds after the skin puncture
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)
Time frame: at 30 and 120 seconds after the skin puncture
Change of analgesic efficacy Visual Analogue Scale (VAS)
The analgesic efficacy of sucrose 24% administration (single Vs multiple doses) during blood sampling using indirect Visual Analogue Scale (VAS).
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Through study completion, an average of 1 year
Intra--hospital outcome Mechanical Ventilation (MV) duration
Intra--hospital outcome MV duration
Time frame: Through study completion, an average of 1 year
Intra--hospital outcome non-Invasive MV (nIMV) duration
Intra--hospital outcome nIMV duration
Time frame: Through study completion, an average of 1 year
Intra--hospital outcome oxygen dependence duration
Intra--hospital outcome oxygen dependence
Time frame: Through study completion, an average of 1 year
Intra--hospital outcome rate of Bronchopulmonary Dysplasia (BPD)
Intra--hospital outcome rate of BPD
Time frame: Through study completion, an average of 1 year
Intra--hospital outcome rate of Pneumothorax (PNX)
Intra--hospital outcome rate of PNX
Time frame: Through study completion, an average of 1 year
Intra--hospital outcome rate of Patent ductus arteriosus (PDA)
Intra--hospital outcome rate of PDA
Time frame: 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
Time frame: 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
Time frame: within 28 days of life
Intra--hospital outcome incidence hydrocephalus
Intra--hospital outcome incidence of hydrocephalus
Time frame: Through study completion, an average of 1 year
Intra--hospital outcome time to Full Enteral Feeding (FEF)
Intra--hospital outcome time to FEF
Time frame: 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)
Time frame: Through study completion, an average of 1 year
Intra--hospital outcome rate of proved sepsis
Intra--hospital outcome rate of proved sepsis
Time frame: Through study completion, an average of 1 year
Intra--hospital outcome rate of suspected sepsis
Intra--hospital outcome rate of suspected sepsis
Time frame: Through study completion, an average of 1 year
Intra--hospital outcome rate of Retinopathy of Prematurity (ROP)
Intra--hospital outcome rate of ROP
Time frame: Through study completion, an average of 1 year
Intra--hospital outcome time to regain birth weight
Intra--hospital outcome time to regain birth weight
Time frame: Through study completion, an average of 1 year
Intra--hospital outcome hospitalization length
Intra--hospital outcome hospitalization length
Time frame: 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
Time frame: Through study completion, an average of 1 year
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Safety \[achieved by monitoring and registering adverse events (AEs), serious adverse events (SAEs) even those unexpected (SUSARs), and measuring vital signs\]
Time frame: Through study completion till patient discharge, an average of 1 year
Plan to share: Undecided
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University Hospital Padova