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

Withdrawn

• Conditions: nerve pain; neuropathic pain; 10034606

• Registration Number: NL-OMON36563
• Lead Sponsor: Medisch Centrum Alkmaar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 28

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- overall pain relief. Measurement of pain intensity using a VAS-score</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>impact of S(+)-ketamine treatment on quality of life<br /><br>impact of S(+)-ketamine treatment on health status(Pain disability index)<br /><br>impact of S(+)-ketamine treatment on symptoms of neuropathic pain</p><br>