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

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ClinicalTrials.gov Identifier: NCT00761059
Recruitment Status : Unknown
Verified February 2009 by University of Cologne.
Recruitment status was:  Recruiting
First Posted : September 26, 2008
Last Update Posted : February 25, 2009
Sponsor:
Information provided by:
University of Cologne

Brief Summary:

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 or disease Intervention/treatment Phase
Analgesia Drug: Glucose 20% Drug: Aqua Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (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
Study Start Date : October 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
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




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


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. med Christoph Huenseler, University of Cologne
ClinicalTrials.gov Identifier: NCT00761059     History of Changes
Other Study ID Numbers: Uni-Koeln-905
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: February 25, 2009
Last Verified: February 2009

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