Role of Oral Sucrose in Reducing the Pain to Orogastric Tube Insertion in Preterm Neonates
This study has been completed.
Sponsor:
Lady Hardinge Medical College
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
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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:
MedlinePlus related topics:
Drinking Water
Drug Information available for:
Sucrose
U.S. FDA Resources
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 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 May 22, 2013