Analgesic Efficacy of Oral Glucose in Preterm Neonates During Suctioning

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Glucose 20%

Group Type ACTIVE_COMPARATOR

Glucose 20%

Intervention Type DRUG

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

placebo

Group Type PLACEBO_COMPARATOR

Aqua

Intervention Type DRUG

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

Interventions

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Glucose 20%

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

Intervention Type DRUG

Aqua

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

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No