Intravenous Treatments Used in Medication Overuse Headache Bridge Treatment
NCT ID: NCT05608642
Last Updated: 2022-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
45 participants
INTERVENTIONAL
2022-10-22
2023-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group given intravenous hydration
The first group consists of patients given 500 cc intravenous saline for 1 hour.
Intravenous hydration
500 cc intravenous serum for 1 hour in the first group service consists of patients who have been given.
Group given intravenous prednisolone
Second group; consists of patients who were given 80 mg of intravenous prednisolone for the first 4 days and then given gradually decreasing doses of prednisolone in the following days.
Intravenous prednisolone
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.
Group given intravenous lidocaine
Third group; includes patients given 2 mg/kg intravenous lidocaine by 1-hour infusion.
Intravenous lidocaine
The third group includes patients in whom 2 mg/kg of intravenous lidocaine is given by 1-hour infusion.
Interventions
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Intravenous hydration
500 cc intravenous serum for 1 hour in the first group service consists of patients who have been given.
Intravenous prednisolone
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.
Intravenous lidocaine
The third group includes patients in whom 2 mg/kg of intravenous lidocaine is given by 1-hour infusion.
Eligibility Criteria
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Inclusion Criteria
* Chronic migraine
Exclusion Criteria
* Pregnancy
* Epilepsia
* Heart disease
* Bradikardia
* Hypertension
* Diabetes mellitus
18 Years
65 Years
ALL
No
Sponsors
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Diskapi Teaching and Research Hospital
OTHER
Responsible Party
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Damla Yürük
Director
Principal Investigators
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Ömer Taylan Akkaya
Role: STUDY_CHAIR
Diskapi Yildirim Beyazıt Teaching and Research Hospital
Gevher Rabia Genç Perdecioğlu
Role: STUDY_DIRECTOR
Diskapi Yildirim Beyazıt Teaching and Research Hospital
Hüseyin Alp Alptekin
Role: PRINCIPAL_INVESTIGATOR
Diskapi Yildirim Beyazıt Teaching and Research Hospital
Locations
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Diskapi Yildirim Beyazıt Teaching and Research Hospital
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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Medication Overuse Headache
Identifier Type: -
Identifier Source: org_study_id
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