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IRCT20201202049575N1 IRCT 2020-12-09 Arak University of Medical Sciences The effect of morphine and oxycodone on bone metastatic pain Comparison of the effect of morphine and oxycodone in relieving pain in patients with bone metastasis pain 2020-12-21 anticipated 32 Complete https://irct.ir/trial/52795 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using block randomization method and online statistical software (www.sealedenvelope.com), 32 patients will be divided into two equal groups of intervention and control in 8 blocks of 4. To hide random sequences, the sealed envelope method is used. First, a random sequence is created by one of the mentioned methods. , Are prepared and each of the random sequences created is recorded on a card and the cards are placed in the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants into the study, one of the envelopes is opened in order and the assigned group of the participant is revealed, Blinding description: Due to the double-blindness of the study, blindness is such that only the relevant specialist in charge is aware of the type of the study and groups , while patients are not aware of the type of prescription drug and blind using injectable and oral placebo. Also, the clinical caregivers and interns in charge of the project, who are in charge of filling out the checklists, are not aware of the type of groups based on the prescription drug and only recognize the groups based on A and B and check the checklists. 3 Bone metastasis. Intervention 1: First intervention group: In the first group, 16 patients received morphine sulfate (Darupakhsh-Iran) 5 mg intravenously once at the beginning of the intervention and two placebo tablets orally once at the beginning of the intervention. Intervention 2: Second intervention group: In the second group, 16 patients receive two 5 mg oxycodone tablets (Shafa-Iran) orally and simultaneously, and only once at the beginning of the intervention and an injectable placebo of 5 ml, once at the beginning of the intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mahdi Farahani
Payambar-e-azam Complex, Basij Sq., Sardasht
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3639 research@arakmu.ac.ir Arak University of Medical Sciences scientific Mahdi Farahani
Payambar-e-azam Complex, Basij Sq., Sardasht
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3645 research@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) All patients with malignancy whose bone metastasis has been confirmed by bone scan and are candidates for analgesia. Pain intensity less than 6 based on vas ruler 18 years 60 years Both Have low blood pressure, Bradypnea Have a bone fractures History of diabetes and kidney failure C41 Malignant neoplasm of bone and articular cartilage of other and unspecified sites Treatment - Drugs Treatment - Drugs First intervention group: In the first group, 16 patients received morphine sulfate (Darupakhsh-Iran) 5 mg intravenously once at the beginning of the intervention and two placebo tablets orally once at the beginning of the intervention. Second intervention group: In the second group, 16 patients receive two 5 mg oxycodone tablets (Shafa-Iran) orally and simultaneously, and only once at the beginning of the intervention and an injectable placebo of 5 ml, once at the beginning of the intervention. Pain. Timepoint: Before the intervention, 30 minutes, 2 hours and 6 hours after the intervention. Method of measurement: visual analogue scale for pain. Arak University of Medical Sciences Approved 2020-11-08 thics committee of Arak University of Medical Sciences Payambar-e-azam Complex, Basij Sq., Sardasht Arak Markazi Iran (Islamic Republic of)