Role of Oral Sucrose in Reducing the Pain to Orogastric Tube Insertion in Preterm Neonates

This study has been completed.
Sponsor:
Information provided by:
Lady Hardinge Medical College
ClinicalTrials.gov Identifier:
NCT00949104
First received: July 29, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

RESEARCH HYPOTHESIS Orally administered sucrose 2 minutes prior to the procedure of OGT insertion reduces pain associated with the procedure.

AIMS AND OBJECTIVES:

To study the effect of 24% oral sucrose on decreasing the painful response to orogastric tube insertion .


Condition Intervention Phase
Pain in Preterm Neonates
Drug: Sucrose
Drug: Double distilled water
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Assess the Role of Oral Sucrose in Reducing the Pain to Orogastric Tube Insertion in Preterm Neonates

Resource links provided by NLM:


Further study details as provided by Lady Hardinge Medical College:

Primary Outcome Measures:
  • Painful response as assessed by PIPP Scale [ Time Frame: Pre procedure,Intra procedure,post 30 sec,post 1 min,post 2 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum heart rate and minimum oxygen saturation [ Time Frame: pre procedure,intra procedure,post 30 seconds,post 1 minute,post 2 minute ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: January 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sucrose
1 ml of 24% sucrose was administered 2 minutes before the procedure
Drug: Sucrose
1 ml of 24% sucrose was administered 2 minutes prior to the procedure
Other Name: 24%Sucrose
Placebo Comparator: Placebo
Double distilled water
Drug: Double distilled water
1 ml of double distilled water (Placebo) was administered 2 minutes prior to the procedure
Other Name: Double distilled water

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 167 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All pre-terms ( < 37 weeks of gestational age.)
  • Within the first 7 days postnatal days (</=168 hours).
  • Clinically stable from respiratory, hemodynamic and metabolic point of view.
  • Who have not received any painful stimulus at least 30 minutes prior to the intervention.
  • Requiring routine orogastric tube insertion within the first 7 days of life.
  • Only the first attempt at putting OGT in controlled NICU environment will be considered

Exclusion Criteria:

The neonates with the following characteristics will be excluded from the study:

  • Neonates requiring ventilatory support.
  • Neonates requiring oxygen supplementation.
  • Having any facial congenital anomalies.
  • Having any neurological impairment.
  • Receiving opiates or born to mothers receiving opiates.
  • New born babies to whom muscle relaxants, sedatives and analgesics have been administered.
  • With grade 3 and 4 IVH.
  • With major congenital anomalies
  • Any history of birth trauma especially involving face or scalp (including cephalhematoma/ subgaleal bleed).
  • Face presentation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949104

Locations
India
Lady Hardinge Medical College
New Delhi, India, 110001
Sponsors and Collaborators
Lady Hardinge Medical College
Investigators
Study Chair: VIKRAM DATTA, MD,DNB LADY HARDINGE MEDICAL COLLEGE,NEW DELHI,INDIA
  More Information

No publications provided

Responsible Party: DR Vikram Datta, Lady Hardinge Medical College,New Delhi
ClinicalTrials.gov Identifier: NCT00949104     History of Changes
Other Study ID Numbers: OGTPAIN
Study First Received: July 29, 2009
Last Updated: July 29, 2009
Health Authority: India: Institutional Review Board

Keywords provided by Lady Hardinge Medical College:
Sucrose
pain
neonate
preterm
orogastric tube

ClinicalTrials.gov processed this record on April 16, 2014