Nasogastric Tube in Premature Babies - Pain and Treatment - Full Text View

Sponsor:	Norwegian University of Science and Technology
Collaborator:	St. Olavs Hospital
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00218946

Purpose

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

Condition	Intervention	Phase
Infant, Premature	Drug: Sucrose Device: Pacifier	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Caregiver)
Official Title:	Nasogastric Tube in Premature Babies - Pain and Treatment. A Randomised, Partly Blinded, Placebo-Controlled Factorial Clinical Trial of Sucrose and Pacifier

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies

Drug Information available for: Sucrose

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Pain measured on PIPP (Premature Infant Pain Profile) scale [ Time Frame: 4 week to complete ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	January 2005
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 1 no fluid, no pacifier	Drug: Sucrose fluids: 30 % sucrose or sterile water Pacifier: yes or no Device: Pacifier Yes or no
Experimental: 2 water, no pacifier	Drug: Sucrose fluids: 30 % sucrose or sterile water Pacifier: yes or no Device: Pacifier Yes or no
Experimental: 3 Sucrose, no pacifier	Drug: Sucrose fluids: 30 % sucrose or sterile water Pacifier: yes or no Device: Pacifier Yes or no
Experimental: 4 No fluid, pacifier	Drug: Sucrose fluids: 30 % sucrose or sterile water Pacifier: yes or no Device: Pacifier Yes or no
Experimental: 5 water, pacifier	Drug: Sucrose fluids: 30 % sucrose or sterile water Pacifier: yes or no Device: Pacifier Yes or no
Experimental: 6 sucrose, pacifier	Drug: Sucrose fluids: 30 % sucrose or sterile water Pacifier: yes or no Device: Pacifier Yes or no

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.

Eligibility

Ages Eligible for Study:	up to 8 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

28 - 32 weeks gestational weeks
not on mechanical ventilation

Exclusion Criteria:

high risk group regarding cerebral prognosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218946

Locations

Norway
St. Olavs University Hospital
Trondheim, Norway, N-7006

Sponsors and Collaborators

Norwegian University of Science and Technology

St. Olavs Hospital

Investigators

Study Director:

Eirik Skogvoll, MD, PhD

Norwegian University of Science and Technology

More Information

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kristoffersen L, Skogvoll E, Hafström M. Pain reduction on insertion of a feeding tube in preterm infants: a randomized controlled trial. Pediatrics. 2011 Jun;127(6):e1449-54. Epub 2011 May 2.

Responsible Party:	Eirik Skogvoll, MD PhD, Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00218946 History of Changes
Other Study ID Numbers:	NISE-2005-1
Study First Received:	September 20, 2005
Last Updated:	February 2, 2009
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

pain,premature,nasogastric tube,PIPP

ClinicalTrials.gov processed this record on February 12, 2012