Analgesic Efficacy of Oral Glucose in Preterm Neonates During Suctioning
Not Applicable
- Conditions
- Analgesia
- Interventions
- Drug: Glucose 20%Drug: Aqua
- Registration Number
- NCT00761059
- Lead Sponsor
- University of Cologne
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Glucose 20% Glucose 20% - placebo Aqua -
- Primary Outcome Measures
Name Time Method The PIPP-Score, a validated pain-score, is used to measure the patient's pain during nasopharyngeal suctioning
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Neonatology, Children's Hospital, University of Cologne
🇩🇪Cologne, Germany