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IRCT201510251598N3 IRCT 2016-02-16 Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences Comparing effect of tizanidine hydrochloride vs. placebo on muscle cramp in hemodialysis patients Comparing effect of tizanidine hydrochloride vs. placebo on muscle cramp in hemodialysis patients in 2010-03-20 anticipated 20 Complete https://irct.ir/trial/1009 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Prevention. 3 muscle cramp in hemodialysis patients. Intervention 1: Group A at first receives tizanidine hydrochloride for one month and after 3 days washout period receives placebo for another month. Serum Na, K, calcium, phosphate, albumin, and complete blood cell count are measured before each phase of study. Patients’ systolic and diastolic blood pressure and pulse rate are monitored at the time of drug or placebo administration and at the start of each hemodialysis session and then hourly till the end of hemodialysis and at the start of each muscle cramp episode. The number of muscle cramps in each hemodialysis session are recorded by responsible hemodialysis nurse. At the start of each muscle cramp episode duration and intensity of muscle cramp is measured by corresponding hemodialysis nurse. Intensity of muscle cramp is measured by visual analog scale from zero to ten specified by patients on the questionnaire. After starting muscle cramp the patients will be treated by hypertonic saline to abort the muscle cramp. Intervention 2: Group B at first receives placebo for one month and after 3 days washout period receives tizanidine hydrochloride for another month. Serum Na, K, calcium, phosphate, albumin, and complete blood cell count are measured before each phase of study. Patients’ systolic and diastolic blood pressure and pulse rate are monitored at the time of drug or placebo administration and at the start of each hemodialysis session and then hourly till the end of hemodialysis and at the start of each muscle cramp episode. The number of muscle cramps in each hemodialysis session are recorded by responsible hemodialysis nurse. At the start of each muscle cramp episode duration and intensity of muscle cramp is measured by corresponding hemodialysis nurse. Intensity of muscle cramp is measured by visual analog scale from zero to ten specified by patients on the questionnaire. After starting muscle cramp the patients will be treated by hypertonic saline to abort the muscle cramp.
public Dr. Shahram Taheri
Isfahan Kidney Diseases Research Center, Alzahra Hospital- Soffeh Ave.
Isfahan Iran (Islamic Republic of) +98 32 3625 5555 sh_taheri@med.mui.ac.ir, shah63tah@yahoo.com Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences scientific Dr. Shahram Taheri
Isfahan Kidney Diseases Research Center, Alzahra Hospital, Soffeh Ave.
Isfahan Iran (Islamic Republic of) +98 31 3625 5555 sh_taheri@med.mui.ac.ir, shah63tah@yahoo.com Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: At least 18 year old; give informed consent to participate in the 2 month clinical trial; at least has once weekly muscle cramp episode during previous month; stable hemodialysis patients and no hypotension during muscle cramp episode (Systolic BP≥90 mmHg); chronic hemodialysis patients for at least 3 months; serum calcium level≥ 8.3 mg/dL; serum sodium level≥ 135 mEq/L Exclusion criteria: side effect appearing to tizanidine; any time patient wishes to exit from the study. 18 years 99 years Both R25.2,Z49. Cramp and spasm,Extracorporeal dialysis Prevention Prevention Group A at first receives tizanidine hydrochloride for one month and after 3 days washout period receives placebo for another month. Serum Na, K, calcium, phosphate, albumin, and complete blood cell count are measured before each phase of study. Patients’ systolic and diastolic blood pressure and pulse rate are monitored at the time of drug or placebo administration and at the start of each hemodialysis session and then hourly till the end of hemodialysis and at the start of each muscle cramp episode. The number of muscle cramps in each hemodialysis session are recorded by responsible hemodialysis nurse. At the start of each muscle cramp episode duration and intensity of muscle cramp is measured by corresponding hemodialysis nurse. Intensity of muscle cramp is measured by visual analog scale from zero to ten specified by patients on the questionnaire. After starting muscle cramp the patients will be treated by hypertonic saline to abort the muscle cramp. Group B at first receives placebo for one month and after 3 days washout period receives tizanidine hydrochloride for another month. Serum Na, K, calcium, phosphate, albumin, and complete blood cell count are measured before each phase of study. Patients’ systolic and diastolic blood pressure and pulse rate are monitored at the time of drug or placebo administration and at the start of each hemodialysis session and then hourly till the end of hemodialysis and at the start of each muscle cramp episode. The number of muscle cramps in each hemodialysis session are recorded by responsible hemodialysis nurse. At the start of each muscle cramp episode duration and intensity of muscle cramp is measured by corresponding hemodialysis nurse. Intensity of muscle cramp is measured by visual analog scale from zero to ten specified by patients on the questionnaire. After starting muscle cramp the patients will be treated by hypertonic saline to abort the muscle cramp. Muscle cramp frequency. Timepoint: During hemodialysis session. Method of measurement: Observation by responsible hemodialysis nurse. Muscle cramp intensity. Timepoint: During hemodialysis session. Method of measurement: Visual analog scale. Muscle cramp duration (second). Timepoint: During hemodialysis session. Method of measurement: Measuring by responsible nurse. Systolic and diastolic blood pressure. Timepoint: At the time of tizanidine hydrochloride or placebo prescription and then at the start of hemodialysis session and hourly during hemodialysis and at the start of each muscle cramp episode. Method of measurement: Sphigmomanometer by responsible nurse. Pulse rate (beats per minute). Timepoint: At the time of tizanidine hydrochloride or placebo prescription and then at the start of hemodialysis session and hourly during hemodialysis and at the start of each muscle cramp episode. Method of measurement: watch, by responsible nurse. Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences Approved 2009-11-03 Medical research ethics committee at the Isfahan University of Medical Sciences Research vice president of Isfahan University of Medical Sciences , Building 4, Hezar Jerib St. Isfahan Iran (Islamic Republic of)