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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014