MedTrace Logo

Analgesic Effect of Oral 25% Glucose Versus Oral 24% Sucrose for Pain Relief During Heel Lance in Preterm Neonates

NCT01931020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2016-06-27

No results posted yet for this study

Summary

RESEARCH HYPOTHESIS-In preterm neonates during heel lance oral 25% glucose is more efficacious in reducing pain as compared to oral 24% sucrose when assessed by PIPP(Premature infant pain profile)

Conditions

Interventions

DRUG

Sucrose

The enrolled neonates will be administered 1ml of 24% sucrose. After 2 minutes heel lancing will be performed after cleaning the heel of neonate with a sterile spirit swab, with an auto lancet. Neonate's faces and monitor screen will be filmed in real time by using two independent video cameras during the entire procedure i.e. staring 2 minutes prior to heel lance and continue 2 minutes after the procedure. The PIPP will be assessed at 30 seconds, 1 minute and 2 minute after the procedure.

DRUG

Glucose

The enrolled neonates will be administered 1ml of 25% gluose. After 2 minutes heel lancing will be performed after cleaning the heel of neonate with a sterile spirit swab, with an auto lancet. Neonate's faces and monitor screen will be filmed in real time by using two independent video cameras during the entire procedure i.e. staring 2 minutes prior to heel lance and continue 2 minutes after the procedure. The PIPP will be assessed at 30 seconds, 1 minute and 2 minute after the procedure.

Sponsors & Collaborators

  • Lady Hardinge Medical College

    lead OTHER_GOV

Principal Investigators

  • Vikram Datta, MD · Lady Hardinge Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
34 Weeks
Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01931020 on ClinicalTrials.gov