Role of Oral Sucrose in Reducing the Pain to Orogastric T... | NCT00949104

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

NCT00949104

Sponsor

Lady Hardinge Medical College

Status

Completed

Last Update Posted

Jul 30, 2009Estimated

Enrollment

120Actual

Phase

Phase 2Phase 3

Conditions

Pain in Preterm Neonates

Interventions

Sucrose
Double distilled water

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Jul 29, 2009

First Submission Date that Met QC Criteria

Jul 29, 2009

First Posted Date

Jul 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2009

Last Update Posted Date

Jul 30, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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 .

Detailed Description

MATERIAL & METHODS

PARTICPANTS:

INCLUSION CRITERIA: The enrolled participants must fulfill the following inclusion criteria:

All pre-terms ( < 37 weeks of gestational age.)
Within the first 7 days postnatal days (\

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sucrose	Active Comparator	1 ml of 24% sucrose was administered 2 minutes before the procedure	Drug: Sucrose
Placebo	Placebo Comparator	Double distilled water	Drug: Double distilled water

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sucrose	Drug	1 ml of 24% sucrose was administered 2 minutes prior to the procedure	Sucrose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Painful response as assessed by PIPP Scale		Pre procedure,Intra procedure,post 30 sec,post 1 min,post 2 minutes

Secondary Outcomes

Measure	Description	Time Frame
Maximum heart rate and minimum oxygen saturation		pre procedure,intra procedure,post 30 seconds,post 1 minute,post 2 minute

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All pre-terms ( < 37 weeks of gestational age.)
Within the first 7 days postnatal days (\

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Hour

Maximum Age

167 Hours

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
VIKRAM DATTA, MD,DNB	LADY HARDINGE MEDICAL COLLEGE,NEW DELHI,INDIA	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lady Hardinge Medical College		New Delhi	New Delhi	110001	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23263970	Derived	Pandey M, Datta V, Rehan HS. Role of sucrose in reducing painful response to orogastric tube insertion in preterm neonates. Indian J Pediatr. 2013 Jun;80(6):476-82. doi: 10.1007/s12098-012-0924-4. Epub 2012 Dec 21.

ID	Term
D010146	Pain
D047928	Premature Birth

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D007752	Obstetric Labor, Premature

ID	Term
D004187	Disaccharides
D009844	Oligosaccharides
D011134	Polysaccharides
D002241	Carbohydrates