Palliative Morphine With or Without Concurrent Modafinil
Prospective Randomized Study Evaluating the Effects of Modafinil in Patients Receiving Oral Morphine for Pain Palliation
Lead SponsorDr. Rajendra Prasad Government Medical College
Indication/ConditionExcessive Sleepiness Cancer Pain Palliation
Oral morphine is often utilized as a convenient and effective method of achieving palliation of pain in the terminally ill cancer patients. However, at effective doses, a majority of patients do experience an undue amount of excessive sleepiness. Given the generally low expected survival periods among this patient population, the fact that morphine causes the patient to spend a significant period of remaining life in sleep, is often unacceptable for the patients and their families. Given the proven benefits of modafinil in conditions characterized by excessive sleepiness (such as with narcolepsy and shift-work disorder), the investigators designed a prospective placebo controlled randomized trial by the addition of modafinil at a dose of 200mg per day (in two divided doses) for eligible patients after randomization.
Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation
Oral placebo b.i.d, along with the dose of oral morphine required for pain palliation
Inclusion Criteria: Diagnosed and confirmed malignancy Able to orally consume tablets Blood Pressure: Systolic <144mmHg; Diastolic <92mmHg Normal blood sugar No active systemic infections Consenting Oral morphine being consumed as a part of terminal symptom palliation Exclusion Criteria: Candidates receiving oral morphine for temporary pain management, such as being potential candidates for radical curative approaches in the future Poor performance status (Karnofsky Performance Status score <50) Prior history of hypertension, diabetes, tuberculosis, epilepsy Prior history of psychiatric and neurological illness