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

NCT05236647 | Completed Phase 3 DMC

• 1 other identifier: 2021/291056(REK)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of patients not reaching adequate pain relief.

  48 hours

• Number of bolus doses first 24 hours and 48 hours

  24 and 48 hours

• Time from bolus administration to clinically significant pain relief

  60 minutes

• Time to maximum plasma concentration (Tmax).

  120 minutes

• Maximum plasma concentration (Cmax).

  120 minutes

Study Arms (2)

Intravenous morphine infusion

EXPERIMENTAL

Morphine 10 mg/ml or morphine 20 mg/ml will be diluted with normal saline to 5 mg/ml or 10 mg/ml. Both active study medication and placebo will be prepared in 100 ml drug containers suitable for the infusion pump. The patient will have two similar infusion pumps. Morphine infusion connected to an i.v. line, placebo (normal saline) connected to a s.c line. Bolus dose will initially be equal to dose/hour. The nurse will administer bolus doses on both pumps (placebo and morphine pump) simultaneously. Patient reported pain intensity (NRS 0-10) and whether the bolus dose was initiated by the patient or the nurse will be recorded before each bolus dose. Bolus dose will be equally increased if/when the infusion rate is increased. If the bolus dose is ineffective, the bolus dose can be increased in steps of 0.1 ml until an effective dose is reached.

Drug: Morphine

Subcutaneous morphine infusion

ACTIVE COMPARATOR

Morphine 10mg/ml or morphine 20 mg/ml will be diluted with normal saline to 5 mg/ml or 10 mg/ml. Both active study medication and placebo will be prepared in 100 ml drug containers suitable for the infusion pump. The patient will have two similar infusion pumps. Morphine infusion connected to a s.c. line, placebo (normal saline) connected to a i.v. line. Bolus dose will initially be equal to dose/hour. The nurse will administer bolus doses on both pumps (placebo and morphine pump) simultaneously. Patient reported pain intensity (NRS 0-10) and whether the bolus dose was initiated by the patient or the nurse will be recorded before each bolus dose. Bolus dose will be equally increased if/when the infusion rate is increased. If the bolus dose is ineffective, the bolus dose can be increased in steps of 0.1 ml until an effective dose is reached.

Drug: Morphine

Interventions

Morphine DRUG

Intravenous morphine infusion compared to subcutaneous morphine infusion

Also known as: Morphine hydrochloride trihydrate

Intravenous morphine infusion; Subcutaneous morphine infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead

Study Sites (1)

Akershus University Hospital

Lørenskog, 1478, Norway

Location

MeSH Terms

Conditions

Cancer Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Olav Fredheim, MD PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 11, 2022
• Study Start: March 8, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)