Role of Nefopam in Rituximab Transfusion Reaction

Sponsor
Ministry Of Health / Nineveh Health Directorate (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05648058
Collaborator
(none)
100
2
11

Study Details

Study Description

Brief Summary

the patients will be taken nefopam ampule 50 mg before rituximab in the first group while the second group will be taken diphenhydramine ampule 10 mg before rituximab in the second group

Condition or Disease Intervention/Treatment Phase
  • Drug: Nefopam ampule
  • Drug: diphenhydramine ampule
Phase 3

Detailed Description

the two groups will be taken standard therapy (hydrocortisone vial 100 mg and acetaminophen 1000 mg) 30 min before rituximab

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Role of Nefopam in Rituximab Transfusion Reaction
Anticipated Study Start Date :
Dec 20, 2022
Anticipated Primary Completion Date :
Oct 20, 2023
Anticipated Study Completion Date :
Nov 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: nefopam

administration of intravenous nefopam to prevent Rituximab Transfusion Reaction

Drug: Nefopam ampule
nefopam ampule 50 mg
Other Names:
  • ACUPAN
  • Active Comparator: diphenhydramine

    administration of intravenous diphenhydramine to prevent Rituximab Transfusion Reaction

    Drug: diphenhydramine ampule
    diphenhydramine ampule 10 mg
    Other Names:
  • Allermine
  • Outcome Measures

    Primary Outcome Measures

    1. transfusion reaction [30 min]

      fever, riger, rash, chills, pruritus and bronchospasm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 18 - 80 years old male and female will be taken rituximab
    Exclusion Criteria:
    • less than 18 years old more than 80 years old diabetic patients

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ministry Of Health / Nineveh Health Directorate

    Investigators

    • Study Chair: moataz alani, Ministry Of Health / Nineveh Health Directorate

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ministry Of Health / Nineveh Health Directorate
    ClinicalTrials.gov Identifier:
    NCT05648058
    Other Study ID Numbers:
    • nefopam with rituximab
    First Posted:
    Dec 13, 2022
    Last Update Posted:
    Dec 15, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 15, 2022