Nasopharyngeal suctioning is a painful procedure that often becomes nessecary 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. In this clinical trial the efficacy of glucose 20% for relieving the procedural pain of nasopharyngeal suctioning is tested.
Conditions
Interventions
Trade Name: Glucose 20% B. Braun
Pharmaceutical Form: Solution for injection
CAS Number: 50997
Other descriptive name: GLUCOSE
Concentration unit: % (V/V) percent volume/volume
Concentration type: equ
Sponsors
University of Cologne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Preterm newborns (>1500g birth weight) up to a gestational age of 36+6 weeks 2. CPAP respiratory therapy 3. Parents' given written consent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Diseases complicating neuromuscular evaluation. 2. Drug abuse by the mother 3. Administration of other analgetic or sedative drugs within the previous 48h. 4. Participation in another interventional clinical trial within 4 weeks before the beginning of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: It is the main objective of the trial to examine whether the oral aplication of Glucose 20% reduces the pain during nasopharyngeal suctioning in preterm infants > 1500g under CPAP-Therapy. The procedure of nasopharyngeal suctioning is recorded on video and the PIPP-Score, a validated pain-score, is used to measure the patient's pain.;Primary end point(s): A 30 % reduction of the pain-score (PIPP) in the group of preterm infants recieving glucose during nasopharyngeal suctioning in comparison to the group recieving aqua.;Secondary Objective: The effectiveness of glucose is also measured by a second pain-score, the VAS. Furthermore heart rate and oxygen saturation are measured and interpreted as physiologic parameters of pain. As a non-invasive physiologic parameter for the detection of pain and stress the skin conductance will be measured. Through registration of all AE and SAE the safety of glucose/aqua administration during nasopharyngeal sunctioning is tested. | — |
Countries
Germany
Outcome results
None listed