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Intravenous Treatments Used in Medication Overuse Headache Bridge Treatment

Not Applicable
Active, not recruiting
Conditions
Medication Overuse Headache
Interventions
Other: Intravenous lidocaine
Other: Intravenous hydration
Other: Intravenous prednisolone
Registration Number
NCT05608642
Lead Sponsor
Diskapi Teaching and Research Hospital
Brief 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.

Detailed 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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
45
Inclusion Criteria
  • Medication overuse headache
  • Chronic migraine
Exclusion Criteria
  • Other headaches will not accompany (tension-type headache, cluster...)
  • Pregnancy
  • Epilepsia
  • Heart disease
  • Bradikardia
  • Hypertension
  • Diabetes mellitus

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group given intravenous lidocaineIntravenous lidocaineThird group; includes patients given 2 mg/kg intravenous lidocaine by 1-hour infusion.
Group given intravenous hydrationIntravenous hydrationThe first group consists of patients given 500 cc intravenous saline for 1 hour.
Group given intravenous prednisoloneIntravenous prednisoloneSecond 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.
Primary Outcome Measures
NameTimeMethod
Visual analog scale (VAS)4 weeks

It is a scale that measures the severity of pain. Scored between ''0: no pain'' and ''10: worst pain'' .

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Diskapi Yildirim Beyazıt Teaching and Research Hospital

🇹🇷

Ankara, Turkey

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