Status:
COMPLETED
Role of Oral Sucrose in Reducing the Pain to Orogastric Tube Insertion in Preterm Neonates
Lead Sponsor:
Lady Hardinge Medical College
Conditions:
Pain in Preterm Neonates
Eligibility:
All Genders
1-167 years
Phase:
PHASE2
PHASE3
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 suc...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00949104
Start Date
January 1 2008
End Date
April 1 2009
Last Update
July 30 2009
Active Locations (1)
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1
Lady Hardinge Medical College
New Delhi, New Delhi, India, 110001