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IRCT20210206050268N1 IRCT 2022-02-05 Esfahan University of Medical Sciences Evaluation of the effect of premedication in controlling acute complications of intravenous immunoglobulin injection 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 2022-01-05 anticipated 90 Complete https://irct.ir/trial/59634 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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), Blinding description: 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). 3 premedication use for intravenous immunoglobulin administration. Intervention 1: Intervention group: tablet Naproxen 500 mg 30 minutes before intravenous immunoglobulin injection. Intervention 2: Intervention group: 1 mg/kg Methylprednisolone intravenous 30 minutes before intravenous immunoglobulin injection. Intervention 3: Control group: Placebo tablets are similar in shape and color to naproxen tablets, which are given half an hour before receiving the drug. Also, all patients receive serum before receiving IVIG. Yes - There is a plan to make this available What will be shared: Adverse reactions data can be generally shared in each of the three study groups When: Access period starts 6 months after the results are published To whom: Every one has access. Conditions: Available for meta-analysis. Where to obtain: the project via email How to obtain: By email within a week Comments:
public Nafiseh sadat Mansouri tehrani
No.3,Ostad taj alley,Azar street
Isfahan Iran (Islamic Republic of) 8133845735 +98 31 3233 0676 nm.9311@yahoo.com Esfahan University of Medical Sciences scientific Nafiseh sadat Mansouri tehrani
No.3,Ostad taj alley,Azar street
Isfahan Iran (Islamic Republic of) 8133845735 +98 31 3233 0676 nm.9311@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 will be included in the study. no limit no limit Both The patient's unwillingness to participate in the study T50.Z15 Adverse effect of immunoglobulin Prevention Prevention Placebo Intervention group: tablet Naproxen 500 mg 30 minutes before intravenous immunoglobulin injection Intervention group: 1 mg/kg Methylprednisolone intravenous 30 minutes before intravenous immunoglobulin injection. Control group: Placebo tablets are similar in shape and color to naproxen tablets, which are given half an hour before receiving the drug. Also, all patients receive serum before receiving IVIG. Complications of intravenous immunoglobulin injection based on checklist. Timepoint: Evaluation of complications one and six hours after injection. Method of measurement: checklist. Esfahan University of Medical Sciences Approved 2021-09-14 Ethics committee of Isfahan University of Medical No. 3, Ostad Taj Alley, Azar street Isfahan Isfehan Iran (Islamic Republic of)