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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00761059

Acronym

Glucose FG

Enrollment

Registered

2008-09-26

Start date

2008-10-31

Completion date

2010-12-31

Last updated

2009-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

Keywords

analgesia, infant, premature, glucose, nasopharyngeal suctioning

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.

Interventions

DRUGGlucose 20%

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

DRUGAqua

The oral application of 0,3 ml/kg Aqua 3 minutes before nasopharyngeal suctioning

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Germany

Contacts

Primary ContactChristoph Huenseler, Dr

christoph.huenseler@uni-koeln.de0049-221-478-7190

Backup ContactKatharina Vezyroglou

katharina.vezyroglou@uk-koeln.de0049-221-478-7190

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026