Nasogastric Tube in Premature Babies - Pain and Treatment

Phase 2

Completed

• Conditions: Infant, Premature
• Interventions: Drug: Sucrose; Other: sterile water; Device: Pacifier

• Registration Number: NCT00218946
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

Does sucrose or pacifier influence pain in premature babies when a nasogastric tube is inserted?

Detailed Description

A total of 24 premature babies are randomised to receive either placebo (sterile water), 30 % sucrose, or pacifier in a complete factorial, cross-over design. Pain is rated on the PIPP scale by observers blinded to the procedure other than use of pacifier.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 28 - 32 weeks gestational weeks
• not on mechanical ventilation

Exclusion Criteria

• high risk group regarding cerebral prognosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
sucrose	Sucrose	Sucrose, no pacifier
sucrose and pacifier	Pacifier	sucrose, pacifier
water	sterile water	water, no pacifier
pacifier	Pacifier	No fluid, pacifier
water and pacifier	Pacifier	water, pacifier
sucrose and pacifier	Sucrose	sucrose, pacifier

Primary Outcome Measures

Name	Time	Method
Pain measured on PIPP (Premature Infant Pain Profile) scale	4 week to complete

Trial Locations

Locations (1)

St. Olavs University Hospital; 🇳🇴 Trondheim, Norway