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(352) 733-0111

Treatment of pruritus with intramuscular promethazine

  • Status
    Accepting Candidates
  • Age
    18 Years - 99 Years
  • Sexes
    Female
  • Healthy Volunteers
    Accepts Healthy Volunteers
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Objective

Neuraxial narcotics are commonly used in obstetric patients for cesarean delivery to help with pain control over the first 24 hours after the surgery. The aim is to evaluate effectiveness of promethazine (IMP) treatment of intrathecal morphine induced pruritus (ITIMIP). A treatment for ITMIP, other than naloxone, will allow for increased use of intrathecal narcotics and decrease the use of systemic opioids in the initial post-operative period.

Details

Full study title Assessing Efficacy of Intramuscular Promethazine for the Treatment of Intrathecal Morphine Induced Pruritus
Protocol number OCR40099
ClinicalTrials.gov ID NCT04805073
Phase Phase 4

Eligibility

Inclusion Criteria:

  • Pregnant adult female patients of at least 18 years of age consenting to a cesarean birth

  • Willing to consent to study.

Exclusion Criteria:

  • Male patients

  • Incarceration

  • Inability to communicate with the investigators

  • Allergies to any medications used in the study

  • Possessing any contraindication to spinal anesthesia (lack of consent, elevated intracranial pressure, preexisting neurological disease, thrombocytopenia/coagulopathy, hypovolemia, infection at the site of the procedure)

  • Patients with an already prolonged QTc (>500 ms)

  • Any reason an investigator believes study participation would not be in the best interest of the potential subject.

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

    Jonathan Cates
  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.