Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05608642 |
| Other study ID # |
Medication Overuse Headache |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 22, 2022 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
November 2022 |
| Source |
Diskapi Teaching and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Medication overuse headache is the chronicity of headaches, which occurs more than 15 days a
month, as a result of frequent use of painkillers, opioids or migraine attack drugs
(ergotamine, triptan) in individuals with pre-existing primary headache disease.
In the treatment of this headache, two ways can be followed as slow drug discontinuation or
sudden drug discontinuation. The most commonly used method is the sudden discontinuation of
the overused analgesic agent, the initiation of prophylactic treatment, and then the
application of bridge therapy for 6-10 days. Intravenous hydration, steroids, antiemetics,
neuroleptic drugs and local anesthetic drugs such as lidocaine can be used in bridge
treatment.
Description:
In our clinic, we routinely apply intravenous 1.5 mg/kg lidocaine, intravenous prednisolone
and intravenous saline treatments as bridge treatment to patients diagnosed with medication
overuse headache. In this study, we aimed to compare the efficacy of intravenous lidocaine,
intravenous steroids and intravenous hydration therapy, which were used as bridge therapy
after the cessation of analgesic use in patients with medication overuse headache.
Patients who applied to the algology outpatient clinic and who were diagnosed with drug
overuse headache and treated were evaluated by dividing them into 3 different groups. It was
planned to include 15 patients in each group. The first group consists of patients who were
given 500 cc of intravenous saline for 1 hour in the service. The second group consisted of
patients who were given 80 mg intravenous prednisolone for the first 4 days and then
gradually reduced doses of prednisolone in the following days. The third group includes
patients in whom 2 mg/kg intravenous lidocaine was administered as a 1-hour infusion,
monitored in the ward.
Pain intensity will be evaluated by visual analog scale (VAS) in all patients after
treatment, at 1 month and 3 months. In addition, the number of days with pain and the number
of analgesics used in the 3-month period after the end of the treatment will be evaluated and
the Quality of Life Scale will be applied.
