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IRCT20260907070962N1 IRCT 2026-11-02 Iran University of Medical Sciences Comparison of Ketamine and Morphine for Pain Relief in Patients With Kidney Stones Comparison of Ketamine and Morphine for Pain Control in Patients With Renal Colic: A Randomized Clinical Trial 2026-10-23 anticipated 340 Recruiting https://irct.ir/trial/94203 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: History of opioid use will be recorded as a potential effect modifier, and its influence on treatment response will be evaluated in the statistical analysis. Randomization will be performed independently of opioid use history, Randomization description: Individual randomization will be performed using block randomization with a fixed block size of four and a 1:1 allocation ratio. The random allocation sequence will be generated by an independent statistician using Random Allocation Software. After obtaining informed consent, eligible patients will be randomly assigned to either the intervention or control group. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes (SNOSE). The envelopes will be prepared according to the random allocation sequence and opened sequentially after enrollment of each eligible participant, Blinding description: In this study, participants, treating physicians, outcome assessors, and the data analyst will be blinded to treatment allocation. Study medications will be prepared by a nurse who will not be involved in outcome assessment or data collection. Both medications will be prepared in identical 10-mL syringes, without labels identifying the allocated treatment, and adjusted to the same final volume to maintain a similar appearance. Pain intensity and other study outcomes will be assessed and recorded by a trained researcher who will remain unaware of treatment allocation. Data will be provided to the statistician using coded group identifiers, without revealing the actual treatments. Allocation codes will remain confidential until completion of the study and final analysis and will be disclosed only when medically necessary, such as in the event of a serious adverse reaction. Due to differences in the adverse-effect profiles of the study medications, inadvertent unblinding may occur. 4 Unspecified renal colic. Intervention 1: Intervention group: Patients in this group receive intravenous ketorolac 30 mg plus intravenous ketamine 0.3 mg/kg body weight. Intervention 2: Intervention group: Patients in this group receive intravenous ketorolac 30 mg plus intravenous morphine 0.1 mg/kg body weight. 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 A final decision regarding the sharing of de-identified individual participant data has not yet been made. Data sharing will be considered after study completion, subject to ethical approval and participant confidentiality.
public Mahdieh Khaterizadeh
Firoozabadi Hospital, Fadayian-e Islam Street, near Shahr-e Rey Square, Shahr-e Rey, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1849794113 +98 21 5104 8000 khaterizadeh.m@iums.ac.ir Iran University of Medical Sciences scientific Mahdieh Khaterizadeh
Firoozabadi Hospital, Fadayian-e Islam Street, near Shahr-e Rey Square, Shahr-e Rey, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1849794113 +98 21 5104 8000 khaterizadeh.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 65 years Presentation to the emergency department with a diagnosis of renal colic Pain intensity greater than 4 on the Visual Analog Scale (VAS) Provision of informed consent 18 years 65 years Both 1. Pregnancy Need for immediate surgical intervention History of asthma History of schizophrenia N23 Unspecified renal colic Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group receive intravenous ketorolac 30 mg plus intravenous ketamine 0.3 mg/kg body weight. Intervention group: Patients in this group receive intravenous ketorolac 30 mg plus intravenous morphine 0.1 mg/kg body weight. Change in pain intensity from baseline measured by the Visual Analog Scale (VAS). Timepoint: At baseline and 15, 30, 45, and 60 minutes after intervention. Method of measurement: Pain intensity will be measured using a 0–10 Visual Analog Scale . Change in pain intensity will be calculated relative to baseline. Need for rescue analgesia (fentanyl). Timepoint: At 15, 30, 45, and 60 minutes after intervention. Method of measurement: Recording fentanyl administration (yes/no) if Visual Analogue Scale exceeds 4. Occurrence of adverse events associated with the study medications following intervention. Timepoint: At 15, 30, 45, and 60 minutes after intervention. Method of measurement: Recording nausea, vomiting, dizziness, dysphoria, hallucinations, agitation, decreased consciousness, blood pressure changes, tachycardia, oxygen desaturation, and respiratory depression through clinical assessment and vital sign monitoring. (yes/no for each event). Time required to achieve adequate pain control following study drug administration. Timepoint: 15, 30, 45, and 60 minutes after intervention. Method of measurement: Recording the first assessment time at which the pain score is 3 or less on the Visual Analog Scale, in minutes. Hospital admission rate following the study intervention. Timepoint: At final emergency department disposition. Method of measurement: Recording hospital admission status based on the treating physician's final decision (yes/no). Time from study drug administration to the need for rescue analgesia. Timepoint: At 15, 30, 45, and 60 minutes after intervention. Method of measurement: Recording the time of first intravenous fentanyl administration for a pain score of 4 or higher on the Visual Analog Scale, in minutes. مدت زمان حضور بیمار در بخش اورژانس از زمان ویزیت اولیه تا ترخیص. Timepoint: From initial physician assessment to emergency department discharge. Method of measurement: Calculating the interval between initial physician assessment and emergency department discharge, in minutes. Iran University of Medical Sciences Approved 2026-07-08 Ethics committee of Iran University of Medical Sciences Firoozabadi Hospital, Fadaiyan -e Islam St.,Shahr-e Rey Tehran Tehran Iran (Islamic Republic of)