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
Sponsor study identifier
interventional
60
0 countries
N/A
Study Start
January 1, 2011
Actual (reported)Primary Completion
April 30, 2012
Actual (reported)Study Completion
April 30, 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2011
Actual (reported)April 30, 2012
Actual (reported)April 30, 2012
Actual (reported)March 2, 2017
Actual (reported)March 17, 2017
Actual (reported)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.
Change in the heart rate from Baseline and the maximum heart rate obtained during the procedure
It was measured pre procedure to 30 sec,1 min and 2 minutes post venepuncture
Side effects associated with the administration of sucrose in both the groups.
Any time following 30 minutes of sucrose administration
The enrolled infants were administered sterile solution of 0.2 ml of 24% sucrose (active control) 2 min prior to procedure. 24% sucrose was prepared by mixing 2.4gm of sucrose in 10ml distilled water.
The enrolled infants were administered 0.2 ml of 12% sucrose 2 min prior to procedure. These solution were prepared under all sterile precautions by the laboratory staff unrelated to the study. 12%sucrose was prepared by mixing 1.2 gm of sucrose in 10 ml of distilled water. here were two study groups A \& B. The enrolled infants were administered sterile solution of 0.2 ml of 24% sucrose (active control) 2 min prior to procedure. Out of these solutions 1ml was measured by 1 ml syringe and packed and covered with serially numbered opaque sealed envelopes. At the initiation of venepuncture 2 min prior to procedure 0.2 ml of solution marked with patient serial no was administered by a pre-filled syringe to the patient on the anterior aspect of the tongue avoiding spillage, by the personnel carrying out the procedure. The above mentioned personnel was blinded to the contents of the solution.
VIKRAM DATTA, MD
Lady Hardinge Medical College
60 participants (actual enrollment reported by the registry).
First Submitted
March 2, 2017
Contact the study team to confirm eligibility.
First Posted
March 17, 2017
Study Start
January 1, 2011
Actual (reported)Primary Completion
April 30, 2012
Actual (reported)Study Completion
April 30, 2012
Actual (reported)Last Updated
March 17, 2017
Record last verified: 2017-03
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