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

February 24, 2009 updated by: University of Cologne

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Cologne, Germany, 50672
        • Recruiting
        • Neonatology, Children's Hospital, University of Cologne
        • Contact:
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: Aqua
The oral application of 0,3 ml/kg Aqua 3 minutes before nasopharyngeal suctioning
Active Comparator: Glucose 20%
Drug: Glucose 20%
The oral application of 0,3 ml/kg Glucose 20% 3 minutes before nasopharyngeal suctioning

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Investigators

  • Principal Investigator: Christoph Huenseler, Dr med, Neonatology, Children's Hospital, University of Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

September 24, 2008

First Submitted That Met QC Criteria

September 25, 2008

First Posted (Estimate)

September 26, 2008

Study Record Updates

Last Update Posted (Estimate)

February 25, 2009

Last Update Submitted That Met QC Criteria

February 24, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Uni-Koeln-905

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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