Clinical trial NCT05236647: Subcutaneous Versus Intravenous Morphine When Switching From Oral to Parenteral Route in Palliative Cancer Patients
Official title: The SIM-study: A Randomized Controlled Trial of Subcutaneous Versus Intravenous Morphine When Switching From Oral to Parenteral Route in Palliative Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain Cancer
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time from initiation of i.v./s.c. morphine to stable infusion rate is reached
timeFrame: 48 hours
Secondary outcomes:
measure: Number of patients not reaching adequate pain relief.
timeFrame: 48 hours
measure: Number of bolus doses first 24 hours and 48 hours
timeFrame: 24 and 48 hours
measure: Time from bolus administration to clinically significant pain relief
timeFrame: 60 minutes
measure: Time to maximum plasma concentration (Tmax).
timeFrame: 120 minutes
measure: Maximum plasma concentration (Cmax).
timeFrame: 120 minutes
measure: Area under the plasma concentration versus time curve (AUC).
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
Study officials:
affiliation: University Hospital, Akershus
name: Olav Fredheim, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: