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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00949104
First Posted: July 30, 2009
Last Update Posted: July 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Lady Hardinge Medical College
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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 ]

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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 167 Hours   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: DR Vikram Datta, Lady Hardinge Medical College,New Delhi
ClinicalTrials.gov Identifier: NCT00949104     History of Changes
Other Study ID Numbers: OGTPAIN
First Submitted: July 29, 2009
First Posted: July 30, 2009
Last Update Posted: July 30, 2009
Last Verified: July 2009

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

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications