Clonidine in the treatment of adolescent chronic fatigue syndrome: A pilot study for the NorCAPITAL trial

被引:7
作者
Even Fagermoen
Dag Sulheim
Anette Winger
Anders M Andersen
Nils Tore Vethe
J Philip Saul
Erik Thaulow
Vegard Bruun Wyller
机构
[1] Department of Pediatrics, Oslo University Hospital, University of Oslo, Oslo
[2] Department of Anesthesiology, Oslo University Hospital, University of Oslo, Oslo
[3] Lillehammer County Hospital, Lillehammer
[4] Department of Nursing Education, Oslo University College, Oslo
[5] Department of Pharmacology, Oslo University Hospital, Oslo
[6] Department of Medical Biochemistry, Oslo University Hospital, Oslo
[7] Department of Pediatrics, Medical University of South Carolina, Charleston, SC
[8] Department of Paediatrics, Oslo University Hospital, Nydalen 0424, Oslo
关键词
Adolescents; Adverse effects; Autonomic nervous system; Chronic fatigue syndrome; Clonidine; Head-up tilt test;
D O I
10.1186/1756-0500-5-418
中图分类号
学科分类号
摘要
Background: This pilot study (ClinicalTrials.gov ID: NCT01507701) assessed the feasibility and safety of clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, we assessed clonidine dosage in relation to a) plasma concentration levels, b) orthostatic cardiovascular responses, and c) possible adverse effects. Findings. Five adolescent CFS patients (14-19 years old) received 50 g clonidine twice per day during 14 days in an open, uncontrolled design. Plasma concentration of clonidine was assayed by standard laboratory methods. Changes in orthostatic cardiovascular responses were assessed by a 20 o head-up tilt-test (HUT). Adverse effects were mapped by a questionnaire. After 14 days, C 0 median (range) of clonidine was 0.21 (0.18-0.36) g/L, and C max median (range) of clonidine was 0.41 (0.38-0.56) g/L. Also, supine blood pressures and heart rate were lower during clonidine treatment, and the HUT response was closer to the normal response. No serious adverse effects were registered. Conclusion: Clonidine 50 g BID seems to be safe enough to proceed from a pilot study to a controlled trial in a select group of adolescents with CFS (ClinicalTrials.gov ID: NCT01040429). © 2012 Fagermoen et al.; licensee BioMed Central Ltd.
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