Intravenous Treatments Used in Medication Overuse Headache Bridge Treatment

Diskapi Teaching and Research Hospital

Status: Active, not recruiting

Conditions: Medication Overuse Headache

Treatments: Other: Intravenous lidocaine; Other: Intravenous prednisolone; Other: Intravenous hydration

Study type: Interventional

Funder types: Other

Identifiers

NCT05608642

Medication Overuse Headache

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups

Group given intravenous hydration

Active Comparator group

Description:

The first group consists of patients given 500 cc intravenous saline for 1 hour.

Treatment:

Other: Intravenous hydration

Group given intravenous prednisolone

Active Comparator group

Description:

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.

Treatment:

Other: Intravenous prednisolone

Group given intravenous lidocaine

Active Comparator group

Description:

Third group; includes patients given 2 mg/kg intravenous lidocaine by 1-hour infusion.

Treatment:

Other: Intravenous lidocaine