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Iontophoretic administration of S(+)-ketamine in patients with neuropathic pain

Iontophoretic administration of S(+)-ketamine in patients with neuropathic pain - SKIN study

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36563
Enrollment
28
Registered
2011-11-07
Start date
2011-09-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nerve pain neuropathic pain

Interventions

This trial will be conducted following a complete counterbalancing design. Each patient will be treated with four different doses of S(+)-ketamine (0, 50, 75, and 100 mg) in a random treatment seque

Sponsors

Medisch Centrum Alkmaar
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: patients with neuropathic pain (more than 6 months present) as defined by the IASP Pain detect score > 18 and pain intensity VAS score > 6and the presence of Allodynia (VAS score >4) age between 18 and 75 written informed consent

Exclusion criteria

Exclusion criteria: pregnancy known hypersensitivity towards S(+)-ketamine patients with psychiatric history or under treatment patients with Angina pectoris, acute myocardial infarction, heart failure, heart rhythm disorder patients with a pacemaker and/or an implantable cardioverter defibrillator patients with uncontrollable arterial hypertension patients with glaucoma patients with uncontrollable thryroid dysfunction Hospital Anxiety and Depression Scale (HADS-NL) score > 8 for depression and/or > 8 for anxiety No new analgesic treatment may be initiated 6 weeks before start of the study No change in analgesic treatment may be performed during the trial

Design outcomes

Primary

MeasureTime frame
- overall pain relief. Measurement of pain intensity using a VAS-score

Secondary

MeasureTime frame
impact of S(+)-ketamine treatment on quality of life impact of S(+)-ketamine treatment on health status(Pain disability index) impact of S(+)-ketamine treatment on symptoms of neuropathic pain

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)