Analgesic Efficacy of Oral Glucose in Preterm Neonates During Suctioning

Analgesia Clinical Trial

— Glucose FG  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00761059
• Other study ID #: Uni-Koeln-905
• Status: Recruiting
• Phase: N/A
• First received: September 24, 2008
• Last updated: February 24, 2009
• Start date: October 2008
• Est. completion date: December 2010

Study information

• Verified date: February 2009
• Source: University of Cologne
• Contact: Christoph Huenseler, Dr
• Phone: 0049-221-478-7190
• Email: christoph.huenseler[@]uni-koeln.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Glucose 20%
The oral application of 0,3 ml/kg Glucose 20% 3 minutes before nasopharyngeal suctioning
• Aqua
The oral application of 0,3 ml/kg Aqua 3 minutes before nasopharyngeal suctioning

Locations

Country	Name	City	State
Germany	Neonatology, Children's Hospital, University of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The PIPP-Score, a validated pain-score, is used to measure the patient's pain		during nasopharyngeal suctioning	No