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Analgesic Efficacy of Oral Glucose in Preterm Neonates During Suctioning (Glucose FG)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by University of Cologne.
Recruitment status was:  Recruiting
Information provided by:
University of Cologne Identifier:
First received: September 24, 2008
Last updated: February 24, 2009
Last verified: February 2009

Nasopharyngeal suctioning is a painful procedure that often becomes necessary in the care of preterm infants under CPAP therapy several times a day. Since the use of analgetic and sedative drugs is accompanied with multiple side effects these are usually being avoided. Glucose 20% has been shown to have an analgesic effect when administered to preterm infants previous to some painful procedures (i.e blood sampling).

In this clinical trial the efficacy of orally administered Glucose 20% for relieving the procedural pain of nasopharyngeal suctioning is tested. The investigators' study has a cross-over design and is to include 40 patients.

Condition Intervention
Drug: Glucose 20%
Drug: Aqua

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Prospective, Placebo-Controlled Blinded Clinical Trial to Study the Efficacy of Orally Administered Glucose 20% for Relieving Pain During Nasopharyngeal Suctioning in Preterm Infants > 1500g Under CPAP-Therapy

Resource links provided by NLM:

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • The PIPP-Score, a validated pain-score, is used to measure the patient's pain [ Time Frame: during nasopharyngeal suctioning ]

Estimated Enrollment: 40
Study Start Date: October 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glucose 20% Drug: Glucose 20%
The oral application of 0,3 ml/kg Glucose 20% 3 minutes before nasopharyngeal suctioning
Placebo Comparator: placebo Drug: Aqua
The oral application of 0,3 ml/kg Aqua 3 minutes before nasopharyngeal suctioning


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Preterm newborns (>1500g birth weight) up to a gestational age of 36+6 weeks
  • CPAP respiratory therapy
  • Parents' given written consent

Exclusion Criteria:

  • Diseases complicating neuromuscular evaluation.
  • Drug abuse by the mother
  • Administration of other analgetic or sedative drugs within the previous 48h.
  • Participation in another interventional clinical trial within 4 weeks before the beginning of this trial.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00761059

Contact: Christoph Huenseler, Dr 0049-221-478-7190
Contact: Katharina Vezyroglou 0049-221-478-7190

Neonatology, Children's Hospital, University of Cologne Recruiting
Cologne, Germany, 50672
Contact: Christoph Huenseler, Dr med    0049-221-478-7190   
Contact: Katharina Vezyroglou    0049-221-478-7190   
Sub-Investigator: Katharina Vezyroglou         
Sub-Investigator: Angela Kribs, Dr med         
Sub-Investigator: Bernhard Roth, Professor         
Sub-Investigator: Lars Welzing, Dr med         
Sub-Investigator: Frank Eifinger, Dr med         
Sub-Investigator: Anne Vierzig, Dr med         
Sponsors and Collaborators
University of Cologne
Principal Investigator: Christoph Huenseler, Dr med Neonatology, Children's Hospital, University of Cologne
  More Information

Responsible Party: Dr. med Christoph Huenseler, University of Cologne Identifier: NCT00761059     History of Changes
Other Study ID Numbers: Uni-Koeln-905
Study First Received: September 24, 2008
Last Updated: February 24, 2009

Keywords provided by University of Cologne:
infant, premature
nasopharyngeal suctioning processed this record on May 24, 2017