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Completed

NCT Number: NCT05236647

Subcutaneous Versus Intravenous Morphine When Switching From Oral to Parenteral Route in Palliative Cancer Patients

The investigators aim to establish whether the intravenous or the subcutaneous route of administration has clinically significant advantages when parenteral administration of morphine is started with a combination of continuous infusion and bolus doses in palliative cancer patients.

Patients admitted to a Hospital palliative medicine unit with an indication for parenteral administration of morphine will be recruited.

The patients will have two similar infusion pumps with continuous infusion and bolus function. One infusion pump will be connected to an intravenous line, the other to a subcutaneous line. One pump contains morphine, one placebo. The primary endpoint is the time from initiation of infusion with titration to the final infusion rate that provides pain control is reached.

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Key information

Conditions

Pain Cancer Cancer Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Akershus University Hospital

Lørenskog, 1478, Norway

About this study

Intravenous administration has theoretical advantages in more predictable pharmacokinetics and shorter time to maximum effect. Subcutaneous administration is less invasive, requires less specialized personnel and equipment, and probably poses a lower risk of complications than an intravenous line. Traditionally the subcutaneous route has been the recommended first choice for parenteral administration of opioids for palliative cancer patients.

The investigators aim to establish whether the intravenous or the subcutaneous route of administration has clinically significant advantages when parenteral administration of morphine is started with a combination of continuous infusion and bolus doses in palliative cancer patients.

Patients admitted to a Hospital palliative medicine unit with an indication for parenteral administration of morphine will be recruited.

The patients will have two similar infusion pumps with continuous infusion and bolus function. One infusion pump will be connected to an intravenous line, the other to a subcutaneous line. One pump contains morphine, one placebo. The primary endpoint is the time from initiation of infusion with titration to the final infusion rate that provides pain control is reached. Secondary endpoints are time from bolus administration to pain relief, comparison of Tmax, Cmax, and size of AUC0-60 after bolus doses, the number of bolus doses first 24 and 48 hours, and the number of patients reaching acceptable pain relief within 48 hours.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unsatisfactory pain control despite titration of oral or transdermal opioids
  • Planned discharge to home or nursing home

Exclusion criteria

  • Estimated survival time <2 weeks
  • A clear indication for either intravenous or subcutaneous administration
  • Patient unable to report patient reported outcomes needed in the study due to language barriers or cognitive impairment
  • Impossible to establish venous access

Treatment and study plan

Morphine

Drug

Intravenous morphine infusion compared to subcutaneous morphine infusion

Other names: Morphine hydrochloride trihydrate

Primary outcomes

  1. Time from initiation of i.v./s.c. morphine to stable infusion rate is reached

    Time frame: 48 hours

    Time from initiation of i.v./s.c. morphine to stable infusion rate is reached

Secondary outcomes

  1. Number of patients not reaching adequate pain relief.

    Time frame: 48 hours

    Number of patients in each arm not reaching adequate pain relief within 48 hours.

  2. Number of bolus doses first 24 hours and 48 hours

    Time frame: 24 and 48 hours

    Total number of bolus doses first 24 hours and 48 hours

  3. Time from bolus administration to clinically significant pain relief

    Time frame: 60 minutes

    Time from bolus administration to a reduction of minimum 2 on a 0-10 numeric rating scale.

  4. Time to maximum plasma concentration (Tmax).

    Time frame: 120 minutes

    Time to maximum plasma concentration (Tmax) after bolus dose of morphine.

  5. Maximum plasma concentration (Cmax).

    Time frame: 120 minutes

    Maximum plasma concentration (Cmax) after bolus dose of morphine

  6. Area under the plasma concentration versus time curve (AUC).

    Time frame: 120 minutes

    Area under the plasma concentration versus time curve (AUC) after bolus administration of morphine.

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Registry information

Official study title

The SIM-study: A Randomized Controlled Trial of Subcutaneous Versus Intravenous Morphine When Switching From Oral to Parenteral Route in Palliative Cancer Patients

Acronym: SIM

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2022
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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