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The effect of Ketamine infusion versus prednisolone on patients with medication overuse headache

The effect of Ketamine infusion versus prednisolone on patients with medication overuse headache

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20141023019640N3
Enrollment
60
Registered
2024-06-22
Start date
2024-06-21
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with drug overdose headache (MOH). Drug-induced headache, not elsewhere classified

Interventions

Intervention 1: Intervention group: In this group, the participants will be admitted to Imam Khomeini Hospital of Tehran University of Medical Sciences for 5 days after stopping the drugs and after ca

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Suffering from headache caused by excessive use of medication according to the classification of headache disorders(ICHDI-?) ICHD-? diagnostic criteria of MOH: A) Headache occurring on =?? days/month in a patient with a pre-existing headache disorder.B) Regular overuse for >? months of one or more drugs that can be taken for acute and/or symptomatic treatment of headache.C) Not better accounted for by another ICHD-? diagnosis. Age 18-65 years Willingness and informed consent to participate in research Pain intensity based on NRS =4

Exclusion criteria

Exclusion criteria: History of adverse reaction to ketamine Suffering from kidney failure, liver failure and liver disorders such as hepatitis, cirrhosis and malignancy Hemodynamic instability (BP>120/170, BP<50/90) History of acute psychosis Pregnancy and breastfeeding Acute cardiovascular instability Lack of consent to continue attending any stage of the study The use of narcotic drugs, whether as a pain reliever for headache or as a substitute for drugs Headache caused by another underlying cause

Design outcomes

Primary

MeasureTime frame
Severity of headache. Timepoint: Patients will be evaluated immediately before, 24 hours later, on the third day, on the fifth day, one week after discharge, and 3 months after the intervention through an in-person examination by the pain and anesthesia service. Method of measurement: Numeric Rating Scale (NRS): The numerical rating scale of pain intensity is a graded visual axis that measures the intensity of pain through questions from the patient. This scale has a high correlation with the visual scale of pain intensity (choose a number between 0 and 10, where 0 means no pain and 10 means the worst pain experienced). The preference of numerical rating scale of pain intensity, compared to the visual scale of pain intensity, is because it is easier to understand and use.

Secondary

MeasureTime frame
Side effects of the intervention. Timepoint: immediately before, 24 hours after, day 3, day 5, day 7, and 3 months after the intervention. Method of measurement: By measuring the numerical value of blood pressure and the number of heart beats per minute and the presence or absence of delusions and hallucinations, nausea and vomiting, restlessness and anxiety, anorexia and sleep disorders in patients.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Majedi Ardakani

Tehran University of Medical Sciences

hmajedi@tums.ac.ir+98 21 6119 2490

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026