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

Pain Cancer Clinical Trial

— SIM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05236647
• Other study ID #: 2021/291056(REK)
• Status: Recruiting
• Phase: Phase 3
• Start date: March 8, 2022
• Est. completion date: January 2025

Study information

• Verified date: December 2023
• Source: University Hospital, Akershus
• Contact: Olav Fredheim, MD PhD
• Phone: +47 46808581
• Email: olav.m.fredheim[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain Cancer

Intervention

Drug:
• Morphine
Intravenous morphine infusion compared to subcutaneous morphine infusion

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from initiation of i.v./s.c. morphine to stable infusion rate is reached	Time from initiation of i.v./s.c. morphine to stable infusion rate is reached	48 hours
Secondary	Number of patients not reaching adequate pain relief.	Number of patients in each arm not reaching adequate pain relief within 48 hours.	48 hours
Secondary	Number of bolus doses first 24 hours and 48 hours	Total number of bolus doses first 24 hours and 48 hours	24 and 48 hours
Secondary	Time from bolus administration to clinically significant pain relief	Time from bolus administration to a reduction of minimum 2 on a 0-10 numeric rating scale.	60 minutes
Secondary	Time to maximum plasma concentration (Tmax).	Time to maximum plasma concentration (Tmax) after bolus dose of morphine.	120 minutes
Secondary	Maximum plasma concentration (Cmax).	Maximum plasma concentration (Cmax) after bolus dose of morphine	120 minutes
Secondary	Area under the plasma concentration versus time curve (AUC).	Area under the plasma concentration versus time curve (AUC) after bolus administration of morphine.	120 minutes