Evaluation and comparison of the effect of premedication (Methylprednisolone and Naproxen) with placebo in controlling acute complications of IVIG injection in patients with a diagnosis of neurological disease

Determining the effect of premedication in controlling acute complications of IVIG injection

The clinical trial has three groups (Naproxen and Methylprednisolone and control (placebo)), with parallel groups, one-way blind, randomized, phase 3 on 90 patients using random allocation method for randomization.

The study was performed in Al-Zahra and Kashani medical centers in Isfahan. In the three study groups, one hour and six hours after the patient about side effects are asked based on a checklist, which is also evaluated if symptoms are severe. The severity of complications is determined based on clinical evidence, the need for local or immediate intervention, interference with daily activities, or life-threatening criteria based on common terminology criteria for side effects.Vital signs are assessed one hour and six hours later by a nurse to check for hypotension and sinus tachycardia. Due to the fact that the questionnaire is self-assessed and the patient does not know about the received premedication due to the similarity of the drug form, blinding is performed.

All patients with a diagnosis of neurological disease, including myasthenia gravis, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), etc., who are candidates for IVIG and come to medical centers will be included in the study. There is no age limit and the patient will be excluded from the study if he / she does not want to.

The first group receives 1 mg / kg methylprednisolone injection before receiving the drug, the second group receives oral naproxen 500 mg and the third group received placebo.

Side effects include sinus tachycardia fever blood pressure abdominal pain back pain nausea vomiting chills flushing and etc

Patients are selected by available sampling from among those referred to medical centers. Each patient is assigned a number based on the time of arrival at the center, which is based on a pre-determined list in the control group or receiving Methylprednisolone or Naproxen. The list of 90 is randomly divided between the three study groups using randomization software and each number in the list belongs to one of the three study groups (receiving Naproxen, receiving Methylprednisolone and control).

In this study, participants are explained before obtaining consent and none of them have any information about which group they are in. Since all participants are given placebo or naproxen and all receive serum to receive the drug (which may or may not contain methylprednisolone), they are not aware of which group they belong to. The data analyzer also analyzes the data without knowing the target group (intervention or control).

Adverse reactions data can be generally shared in each of the three study groups

Access period starts 6 months after the results are published

Every one has access.

Available for meta-analysis.

the project via email

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