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

September 24, 2008
February 24, 2009
October 2008
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00761059 on ClinicalTrials.gov Archive Site
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Analgesic Efficacy of Oral Glucose in Preterm Neonates During Suctioning
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Analgesia
  • Drug: Glucose 20%
    The oral application of 0,3 ml/kg Glucose 20% 3 minutes before nasopharyngeal suctioning
  • Drug: Aqua
    The oral application of 0,3 ml/kg Aqua 3 minutes before nasopharyngeal suctioning
  • Active Comparator: Glucose 20%
    Intervention: Drug: Glucose 20%
  • Placebo Comparator: placebo
    Intervention: Drug: Aqua
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2010
December 2009   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
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
Germany
 
NCT00761059
Uni-Koeln-905
No
Dr. med Christoph Huenseler, University of Cologne
University of Cologne
Not Provided
Principal Investigator: Christoph Huenseler, Dr med Neonatology, Children's Hospital, University of Cologne
University of Cologne
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP