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Comparison of the effectiveness of injectable morphine, methadone, and dexamethasone in the management of moderate to severe acute pain in renal colic patients: A randomized, controlled, triple-blind clinical trial

Comparison of the effectiveness of injectable morphine, methadone, and dexamethasone in the management of moderate to severe acute pain in renal colic patients: A randomized, controlled, triple-blind clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230410057871N9
Enrollment
376
Registered
2025-09-10
Start date
2025-09-24
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal colic. Unspecified renal colic

Interventions

Intervention 1: Intervention group: Group 1: Single-dose Ketorolac (30 mg IV) plus morphine. Morphine is administered at 0.1 mg/kg IV (maximum 5 mg) (Darou Pakhsh, Tehran, Iran), diluted with distille

Sponsors

Khoram-Abad University of Medical Sciences
Lead Sponsor

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 pain dysuria, 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: Decreased level of consciousness, Abdominal pain unrelated to renal colic, Hypersensitivity to opioids or NSAIDs, Incorrect diagnosis of renal colic, History of chronic cardiovascular or renal disease, Chronic liver disease, Chronic respiratory disease, Allergy or contraindication to morphine, methadone, or dexamethasone, Seizure disorders, Metabolic diseases, Pregnancy or breastfeeding, Addiction, Systolic blood pressure 38°C, Inability to communicate verbally, History of kidney transplantation, History of gastrointestinal bleeding or active GI bleeding, Use of other analgesics, sedatives, or antidepressants, Asthma, Renal failure, Bleeding disorders, Patients unable to understand the VAS questionnaire, Individuals unwilling to participate in the study

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

arian.karimi@sbmu.ac.ir+98 930 675 7977

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026