Morphine as First Drug for Cancer Pain

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.

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Key information

Conditions

Chronic Pain Agnosia Cancer Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de São Paulo

São Paulo, Brazil

About this study

After approval of the Ethics Committee and signing the consent, a prospective randomized study was performed in patients ≥ 18 years, with locally advanced cancer and / or metastases, and pain intensity ≤ 6. There were excluded patients with difficulty maintaining clinical follow-up, cognitive impairment and prior treatment with opioids. G1 patients were treated according to the guidelines of the WHO analgesic ladder starting at the first step, with paracetamol 1g each 6 hours, maximum dose of 4 g/ day, in the second, codeine (30 mg each 4 hours , maximum dose 360 mg / day and morphine 10 mg each 4 hours in the third step. Patients in G2 started with morphine 10 mg each 4 hours. Adjuvant drugs have been associated when indicated. According to the intensity of pain the medication was changed according to analgesic ladder in G1 patients and adjusted the dose in G2. The cancer therapy as palliative radiotherapy, chemotherapy or hormone therapy was performed by the oncologist.

There were evaluated: pain intensity every 2 wk. by visual analogue scale (VAS), quality of life every 4 wk. through the brief questionnaire of quality of life of the WHO 19, satisfaction with treatment, physical capacity measured by the index of Eastern Cooperative Oncology Group (ECOG) 20, and the need for additional analgesics. Adverse effects were recorded. The study was considered completed with the patient's death or three months of follow-up.

To calculate the minimum sample size was used the program BioEstat 2.0. There were used as reference means and standard deviations values of study with a similar method 5. Considering a confidence level of 95% study power of 80% of the minimum sample of 30 patients for each group, totaling 60 patients. For the statistical analysis was used GraphPad Prism ®. There was used the Student t test for age, weight, height, chi-square test for patient satisfaction, need for complementation, and adverse effects, and Mann-Whitney test for pain intensity, quality of life and physical capacity. A p value of ≤ 0,05 was considered significant. The resultas were expressed as mean ± DP.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Opioid

Drug

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

Other names: Morphine

Primary outcomes

Analgesic effect

Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Morphine as the First Drug for the Treatment of Cancer Pain

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Feb 29, 2012
Registry last updated: Feb 8, 2018

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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