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.

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