Pain Clinical Trial
Official title:
A Study to Assess the Role of Two Different Concentrations of Sucrose to Reduce Pain During Initiation of Venipuncture in Extremely Low Birth Weight Babies
Verified date | March 2017 |
Source | Lady Hardinge Medical College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Newborn infants in the neonatal intensive care nursery experience multiple, painful tissue
damaging procedures daily.
Preterm especially extremely low birth weights and critically ill newborns admitted to a
Neonatal Intensive Care Unit (NICU) undergo repeated skin-breaking procedures that are
necessary for their survival. Sucrose is the accepted clinical standard nonpharmacological
intervention for managing acute procedural pain for these infants.
However its role in extremely low birth weight infants still need to be addressed. The exact
dose and concentration of oral sucrose is still not clear.
When a Medline search was carried out to evaluate the role of two different concentrations
(12% vs 24%) of oral sucrose in reducing pain in extremely low birth weight babies, very
limited data was available. Cochrane Systemic Review also indicated that specific attention
to the efficacy and safety of sucrose administration in extremely low birth weight preterm
infants needs to be further investigated. More so, no work on this aspect was identified
from the Indian subcontinent. Hence, the current study was planned with an aim to study the
effects of 12% and 24% oral sucrose in extremely low birth weight infants during initiation
of venipuncture and also study the side effects if any associated with these concentrations.
This is a preliminary work on this topic, the results would therefore need to be interpreted
with caution. However, the findings and the study design of this work will provide suitable
platform for future well powered studies on this population.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 30, 2012 |
Est. primary completion date | April 30, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 28 Days |
Eligibility |
Inclusion Criteria: - All extremely low birth weight babies (<1000gm) regardless of gestational age being admitted in NICU - Within first 48 hrs of post natal life - Parental consent Exclusion Criteria: - Neonates requiring ventilatory support - Neonates with any neurological impairment (HIE, seizures) - Receiving opiates or born to mothers receiving opiates - Newborns who have received muscle relaxants, sedatives,analgesics - Major congenital anomalies - 5 mins Apgar of less than 7 - Neonates undergoing any surgery - Birth trauma (especially precipitate deliveries) - Instrumental delivery |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Lady Hardinge Medical College |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response to pain as assessed by Neonatal Facial Coding Score (NFCS) | In Neonatal Facial Coding System, ten actions were monitored which included brow bulge,eye squeeze,deepening of nasolabial furrow, open lips,vertical mouth stretch, horizontal mouth stretch,cupping of tongue,chin quiver,lip pursing to form O,and tongue protrusion.Each facial action was coded as 1 for occurrence and 0 for no occurrence/absence. The final score was assigned by adding these ten parameters.Thus minimum score could be 0 and the maximum score 10 for a preterm infants | The NFCS scale was scored at pre-procedure, intra-procedure (during the initiation of venepuncture). and post 30 sec, 1 min & 2 min of procedure. | |
Secondary | Change in the heart rate from Baseline and the maximum heart rate obtained during the procedure | The change in the heart rate from the baseline which was measured pre procedure was recorded.It was indicated as beats/minute. | It was measured pre procedure to 30 sec,1 min and 2 minutes post venepuncture | |
Secondary | Side effects associated with the administration of sucrose in both the groups. | Side effects noted were only the immediate side effects .Total number of neonates in each arm presenting with side effects would be recorded. | Any time following 30 minutes of sucrose administration |
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