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

University of Cologne

Status: Unknown

Conditions: Analgesia

Treatments: Drug: Glucose 20%; Drug: Aqua

Study type: Interventional

Funder types: Other

Identifiers

NCT00761059

Uni-Koeln-905

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Glucose 20%

Active Comparator group

Treatment:

Drug: Glucose 20%

placebo

Placebo Comparator group

Treatment:

Drug: Aqua