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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Cologne.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00761059
First received: September 24, 2008
Last updated: February 24, 2009
Last verified: February 2009
History of Changes
  Purpose

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
Analgesia
 Drug: Glucose 20%
Drug: Aqua

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Premature Babies
Drug Information available for: Dextrose
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761059

Contacts
Contact: Christoph Huenseler, Dr 0049-221-478-7190 christoph.huenseler@uni-koeln.de
Contact: Katharina Vezyroglou 0049-221-478-7190 katharina.vezyroglou@uk-koeln.de

Locations
Germany
Neonatology, Children's Hospital, University of Cologne Recruiting
Cologne, Germany, 50672
Contact: Christoph Huenseler, Dr med     0049-221-478-7190     christoph.huenseler@uni-koeln.de    
Contact: Katharina Vezyroglou     0049-221-478-7190     katharina.vezyroglou@uk-koeln.de    
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
Investigators
Principal Investigator: Christoph Huenseler, Dr med Neonatology, Children's Hospital, University of Cologne
  More Information

No publications provided

Responsible Party: Dr. med Christoph Huenseler, University of Cologne
ClinicalTrials.gov Identifier: NCT00761059     History of Changes
Other Study ID Numbers: Uni-Koeln-905
Study First Received: September 24, 2008
Last Updated: February 24, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
analgesia
infant, premature
glucose
nasopharyngeal suctioning

ClinicalTrials.gov processed this record on May 16, 2013