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Evaluating Morphine Effectiveness Based on Kidney Function in Patients with Sickle Cell Disease During Vaso-occlusive Crisis

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical study aims to improve pain management for individuals with sickle cell disease who are experiencing vaso-occlusive crisis and/or acute chest syndrome while in intensive care. Sickle cell disease is an inherited blood disorder where red blood cells become crescent-shaped and can block blood vessels, causing severe pain episodes. The study focuses on how the kidneys process morphine, which is commonly used to treat severe pain in these patients.

The research evaluates how well the kidneys filter blood (called glomerular filtration) and how this affects morphine processing in the body. By measuring kidney function using iohexol clearance (a reference method) and comparing it to a kidney function estimation tool (CKD-Epi score), researchers hope to determine when standard morphine doses might not provide adequate pain relief for certain patients.

Understanding the relationship between kidney function and morphine effectiveness could help doctors identify which patients need higher initial doses of pain medication. This would allow for more personalized pain management strategies for people with sickle cell disease during painful crises, potentially improving treatment outcomes and patient comfort.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Admission to the study

    You will be admitted to a Continuous Care Unit (CCU) or intensive care unit with a vaso-occlusive crisis (severe pain episodes) or acute chest syndrome related to your sickle cell disease.

    Upon admission, your kidney function will be assessed using a standard blood test that calculates your glomerular filtration rate (GFR) using the CKD-Epi formula, which measures how well your kidneys are filtering blood.

  2. Step 2

    Pain management setup

    You will receive a patient-controlled analgesia (PCA) device containing morphine hydrochloride (1 mg/ml solution). This device allows you to self-administer small doses of morphine when needed for pain relief.

    The healthcare team will record your pain levels using numerical scales where you rate your pain from 0-10. This will help track how effectively your pain is being managed.

  3. Step 3

    Kidney function assessment

    You will receive an injection of iohexol (300 mg I/ml), a substance that helps measure kidney function more precisely.

    Blood samples will be collected at specific intervals to measure how quickly your kidneys clear the iohexol. This is considered a reference method for assessing kidney function.

  4. Step 4

    Morphine clearance monitoring

    Blood samples will be collected to measure how your body processes morphine and its metabolites (M3G and M6G).

    The healthcare team will monitor and record the total amount of morphine you receive over 24 hours and throughout the 7-day study period.

  5. Step 5

    Pain assessment

    Your pain levels will be regularly evaluated using numerical scales over the 24-hour period.

    At the 24-hour mark, you will complete a Patient Global Impression of Change (PGIC) scale to indicate how much your condition has improved or worsened.

  6. Step 6

    Side effect monitoring

    Throughout the study, you will be monitored for possible side effects of morphine including drowsiness, slow breathing, high carbon dioxide levels, itching, constipation, bloating, nausea, vomiting, and difficulty urinating.

    All these observations are part of standard care for patients receiving morphine.

  7. Step 7

    Study completion

    The study data collection will conclude after 7 days or upon your discharge from the hospital, whichever comes first.

    The results will help determine if kidney function affects how well morphine works for pain relief in sickle cell patients, which may lead to more personalized pain management in the future.

Who can join the trial?

7 criteria

  • You must be 18 years or older
  • You must have a known homozygous sickle cell disease (types SS, SC, S-beta+ or S-beta0)
  • You must be admitted to a Continuous Care Unit (CCU) or intensive care unit
  • You must have a clinical diagnosis of vaso-occlusive crisis (painful episode caused by blocked blood vessels) and/or acute chest syndrome (a serious lung complication of sickle cell disease)
  • You must be receiving morphine PCA therapy (patient-controlled analgesia where you can self-administer pain medication)
  • You must have given consent to participate in the study (or a parent/relative has given consent if you are unable to)
  • You must be affiliated with a social security scheme

Who cannot join the trial?

9 criteria

  • If you are under 18 years old or over 75 years old
  • If you are a woman who is pregnant or breastfeeding
  • If you are unable to give your consent to participate in the study
  • If you have a kidney disease (problem with how your kidneys work)
  • If you have a previous history of allergic reaction to morphine or other similar pain medications
  • If you have a previous history of allergic reaction to iohexol (a substance used to measure kidney function in this study)
  • If you are currently taking part in another clinical trial
  • If you do not have health insurance coverage
  • If you have been placed under legal protection (such as guardianship)
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Investigated drugs

Morphine is a medication used for pain relief. In this study, it is being used to treat severe pain experienced during vaso-occlusive crises in patients with sickle cell disease. The researchers are studying how the kidney's ability to filter blood (glomerular filtration) affects how quickly morphine is cleared from the body, which may impact its effectiveness for pain control.

What is already known about the treatment

  • Morphine

    A potent opioid analgesic administered intravenously for managing severe pain, particularly in sickle cell patients experiencing vaso-occlusive crises. It works by binding to opioid receptors in the brain and spinal cord, altering the perception of and emotional response to pain. Morphine is classified as a full opioid agonist and remains a cornerstone treatment for acute severe pain, though its effectiveness can be affected by kidney function since it is primarily eliminated through the kidneys. In patients with reduced glomerular filtration, dosage adjustments may be necessary to prevent accumulation of the drug and its metabolites, which could lead to side effects or inadequate pain control.

  • Iohexol

    A non-ionic, water-soluble radiographic contrast agent used in this study as a reference method for accurately measuring glomerular filtration rate (GFR). When administered intravenously, iohexol is filtered exclusively by the kidneys without being secreted or reabsorbed, making its clearance rate an excellent marker of kidney function. This contrast medium is widely accepted in medical literature as a gold standard for GFR assessment and provides more precise measurements than estimated GFR calculations based on serum creatinine. By using iohexol clearance, researchers can obtain reliable data about kidney function to correlate with morphine effectiveness in sickle cell patients.

Investigated diseases

  • Sickle Cell Disease

    Sickle cell disease is an inherited blood disorder characterized by abnormal hemoglobin that causes red blood cells to become rigid and C-shaped (sickle-shaped). These abnormal cells can block blood vessels, reducing blood flow and oxygen to body tissues. The disease is marked by episodes of intense pain called vaso-occlusive crises that occur when sickle cells block small blood vessels. Over time, sickle cell disease can affect multiple organs including the lungs, kidneys, spleen, and bones. The condition typically manifests in early childhood and varies in severity among affected individuals.

  • Chronic Kidney Disease

    Chronic kidney disease is a condition characterized by gradual loss of kidney function over time. The kidneys filter wastes and excess fluids from the blood, which are then excreted in urine. As kidney function declines, waste products accumulate in the blood. The disease progresses through five stages of increasing severity based on glomerular filtration rate (GFR). CKD may initially present with few symptoms but can eventually lead to complications like high blood pressure, anemia, bone disease, and fluid buildup. The condition develops slowly over months or years and may result from various underlying causes.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511985-34-00Protocol codeDR230314Estimated enrolment100 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

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