renal colic. Unspecified renal colic
Conditions
Interventions
Intervention 1: Intervention group: Group 1: A single dose of Ketorolac (30 mg) combined with Hyoscine (20 mg) in 100 ml of normal saline will be administered intravenously over 10 minutes. Interventi
Sponsors
Khoram-Abad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age over 18 years, Both sexes,Patients with renal colic experiencing acute moderate to severe pain with NVS = 5 and VAS score > 3, History of ureteral stones, Severe flank paindysuria, and macroscopic or microscopic hematuria, Informed consent to participate in the study, Stable vital signs including: Systolic blood pressure = 90 mmHg, Heart rate between 60–120 beats per minute, Respiratory rate between 18–22 breaths per minute, Oxygen saturation = 92%, No use of analgesics or opioids prior to hospital admission
Exclusion criteria
Exclusion criteria: Exclusion criteria include decreased level of consciousness, abdominal pain, hypersensitivity to NSAIDs, incorrect diagnosis of renal colic, history of cardiovascular disease, chronic liver disease, renal disorders, chronic respiratory disease, allergy or contraindication to Hyoscine, Ketorolac, or Aminophylline, use of drugs interacting with Aminophylline (including theophylline- or oxtriphylline-containing drugs, antiepileptic drugs such as phenytoin and carbamazepine, riociguat, cimetidine, disulfiram, fluvoxamine, interferon, mexiletine, propranolol, rifampin, St. John’s wort, ticlopidine), hypersensitivity to xanthines, arrhythmia, hypothyroidism, seizure disorders, metabolic diseases, pregnancy, breastfeeding, substance abuse, systolic blood pressure 38°C, inability to speak, history of kidney transplantation, history of gastrointestinal bleeding or active gastrointestinal hemorrhage, concurrent use of other analgesics, sedatives, antidepressants, pregnancy, breastfeeding, asthma, renal failure, bleeding disorders, inability to understand the VAS questionnaire, or unwillingness to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean pain score and pain intensity. Timepoint: At baseline (upon admission) and at 5, 10, 30, 45, 60, 90, and 120 minutes after drug administration. Method of measurement: Questionnaire (measured by NVS and VAS).;Heart rate. Timepoint: At baseline (upon admission) and at 5, 10, 30, 45, 60, 90, and 120 minutes after drug administration. Method of measurement: Patient monitor.;Respiratory rate. Timepoint: At baseline (upon admission) and at 5, 10, 30, 45, 60, 90, and 120 minutes after drug administration. Method of measurement: Patient monitor.;Systolic and diastolic blood pressure. Timepoint: At baseline (upon admission) and at 5, 10, 30, 45, 60, 90, and 120 minutes after drug administration. Method of measurement: Patient monitor.;Oxygen saturation. Timepoint: At baseline (upon admission) and at 5, 10, 30, 45, 60, 90, and 120 minutes after drug administration. Method of measurement: Patient monitor.;Pain quality. Timepoint: At baseline (upon admission) and at 5, 10, 30, 45, 60, 90, and 120 minutes after drug administration. Method of measurement: Questionnaire (mak gil). | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean duration of pain relief. Timepoint: At 5, 10, 30, 45, 60, 90, and 120 minutes after drug administration. Method of measurement: Time to pain relief / Duration until no further analgesic needed.;Adverse drug effects (headache, dizziness, nausea, vomiting). Timepoint: At 5, 10, 30, 45, 60, 90, and 120 minutes after drug administration. Method of measurement: questionair. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactArian Karimi Rouzbahani
Khoram-Abad University of Medical Sciences
Outcome results
None listed