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Magnesium Associated With Morphine for Cancer Pain Relief

F

Federal University of São Paulo

Status

Completed

Conditions

Cancer-related Problem/Condition

Treatments

Drug: Magnesiun

Study type

Interventional

Funder types

Other

Identifiers

NCT01541111
CEP0153/09

Details and patient eligibility

About

This study is an evaluation of the analgesic effect of magnesium associated with morphine in patients with cancer pain.

Full description

The study is prospective, randomized, double-blind. The patients will be allocated into two groups. After approval by the Ethics Committee and signed informed consent, 40 patients, aged > 18 years of both genders with cancer pain, will be studied.

The patients in group 1 (n = 20) will receive a dose of magnesium sulfate (65 mg) po twice daily. Patients in Group 2 (n = 20) will receive placebo twice a day. The Mg and placebo capsules are identical. Everyone will receive morphine as needed.

Will be recorded: tumor location, factors which worsen the pain, quality of pain. Pain intensity will be assessed by numerical scale from zero to 10 at T0 (first visit) and after 1, 2, 3. and 4wk.

The patient will note the intensity of pain and side effects at home. Functional performance assessment will bes done by the Karnofsky Performance Status Scale. Quality of life will be assessed by the QLQ-c30.

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • After approval by the Ethics Committee and signed informed consent,
  • 40 patients, > 18 years, with cancer pain, and taking morphine (third step of the analgesic ladder recommended by WHO) were studied

Exclusion criteria

  • Were excluded from the study patients with hypersensitivity to drugs and pregnant

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Double Blind

40 participants in 1 patient group

Magnesiun, pain relief, sugar pills
Other group
Description:
Magnesiun 75mg po each 12h pain relief Sugar pills po each 12h
Treatment:
Drug: Magnesiun

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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