Sucrose to Reduce Pain During Initiation of Venipuncture in Extremely Low Birth Weight Babies

NCT03082001 | Completed Phase 3

• 1 other identifier: ELBW PAIN
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neonate; Pain; ELBW

Keywords

Neonate; Pain; ELBW

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

24% Sucrose

ACTIVE COMPARATOR

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.

Drug: 24% Sucrose

12% Sucrose

EXPERIMENTAL

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.

Drug: 12% Sucrose

Interventions

12% Sucrose DRUG

Also known as: SUGAR SOLUTION

12% Sucrose

24% Sucrose DRUG

Also known as: SUGAR SOLUTION

24% Sucrose

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• mins Apgar of less than 7
• Neonates undergoing any surgery
• Birth trauma (especially precipitate deliveries)
• Instrumental delivery

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

MeSH Terms

Conditions

Pain

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• VIKRAM DATTA, MD

  Lady Hardinge Medical College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: There were two study groups A and B. The enrolled infants were administered either sterile solution of 0.2 ml of 24% sucrose or 0.2 ml of 12% sucrose 2 min prior to the procedure. The procedure involved putting first cannula in the dorm of the right hand. A 24 G needle was inserted into the vein after asepsis 2 min after the neonate had been given the allocated solution. The process was divided into three phases, the pre procedure, intraprocedure and post procedure lasting for 4 minutes. Video recording on the face of the neonate was done using a fixed video camera. The NFCS was used to evaluate and score neonatal pain.It was scored at pre, intra and post procedure 30 sec, 1 min and 2 min of the procedure.

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 17, 2017
• Study Start: January 1, 2011
• Primary Completion: April 30, 2012
• Study Completion: April 30, 2012
• Last Updated: March 17, 2017

Record last verified: 2017-03