Morphine as First Drug for Cancer Pain

NCT01541124 | Completed DMC

• 1 other identifier: CEP1133/07
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Objectives: The drugs used as recommended by the WHO does not promote pain relief for all patients with cancer pain. The objective of this study was to evaluate the use of morphine as the first drug for the treatment of moderate cancer pain by visual analogue scale in patients with advanced disease and / or metastases, as an alternative to the recommendations of the WHO analgesic ladder advocated. Methods: The patients without opioid therapy with more than 18 years, were randomly divided into two groups. G1 patients received medication according to the analgesic ladder, starting treatment with non-opioid in the first step, the second weak opioid and opioid potent in the third, and G2 received morphine as first analgesic. There was evaluated the efficacy and tolerability of initial use of morphine every 2 weeks for 3 months. Results: The study was performed in 63 patients. The groups had similar demographics.

Conditions

Chronic Pain

Keywords

cancer pain; analgesia; morphine

Outcome Measures

Primary Outcomes (1)

• Analgesic effect

  evaluate the use of morphine as the first drug for the treatment of moderate cancer pain by visual analogue scale in patients with advanced disease and / or metastases, as an alternative to the recommendations of the WHO analgesic ladder advocated

  3 months

Study Arms (1)

Morphine, Pain intensity

EXPERIMENTAL

For cancer pain treatment, World Health Organization recomends tritation of opioids associated with non steroidal antiinflamatory drugs. This study compares the analgesic effect with diferents dosages in 63 patients with cancer pain.

Drug: Opioid

Interventions

Opioid DRUG

10 mg/pill, po, each 6h, during 6m

Also known as: Morphine

Morphine, Pain intensity

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years, with locally advanced cancer and / or metastases, and pain intensity ≤ 6

You may not qualify if:

• patients with difficulty maintaining clinical follow-up,
• cognitive impairment and prior treatment with opioids

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Universidade Federal de São Paulo

São Paulo, Brazil

Location

MeSH Terms

Conditions

Chronic Pain; Cancer Pain; Agnosia

Interventions

Analgesics, Opioid; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; 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

• Rioko K Sakata, MD, PhD

  Universidade Federal de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pain Clinic Director

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: February 29, 2012
• Study Start: August 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 8, 2018

Record last verified: 2012-02

Locations

BR (1)