Nasogastric Tube in Premature Babies – Pain and Treatment
Overview
Does sucrose or pacifier influence pain in premature babies when a nasogastric tube is inserted?
Full Title of Study: “Nasogastric Tube in Premature Babies – Pain and Treatment. A Randomised, Partly Blinded, Placebo-controlled Factorial Clinical Trial of Sucrose and Pacifier”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Single (Care Provider)
- Study Primary Completion Date: August 2007
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.
Interventions
- Drug: Sucrose
- 30 % sucrose
- Device: Pacifier
- Other: sterile water
Arms, Groups and Cohorts
- No Intervention: control
- no fluid, no pacifier
- Experimental: water
- water, no pacifier
- Experimental: sucrose
- Sucrose, no pacifier
- Experimental: pacifier
- No fluid, pacifier
- Experimental: water and pacifier
- water, pacifier
- Experimental: sucrose and pacifier
- sucrose, pacifier
Clinical Trial Outcome Measures
Primary Measures
- Pain measured on PIPP (Premature Infant Pain Profile) scale
- Time Frame: 4 week to complete
Participating in This Clinical Trial
Inclusion Criteria
- 28 – 32 weeks gestational weeks – not on mechanical ventilation Exclusion Criteria:
- high risk group regarding cerebral prognosis
Gender Eligibility: All
Minimum Age: 3 Days
Maximum Age: 8 Weeks
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Norwegian University of Science and Technology
- Collaborator
- St. Olavs Hospital
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Eirik Skogvoll, MD, PhD, Study Director, Norwegian University of Science and Technology
References
Stevens B, Johnston C, Petryshen P, Taddio A. Premature Infant Pain Profile: development and initial validation. Clin J Pain. 1996 Mar;12(1):13-22. doi: 10.1097/00002508-199603000-00004.
Citations Reporting on Results
Kristoffersen L, Skogvoll E, Hafstrom M. Pain reduction on insertion of a feeding tube in preterm infants: a randomized controlled trial. Pediatrics. 2011 Jun;127(6):e1449-54. doi: 10.1542/peds.2010-3438. Epub 2011 May 2.
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.