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Evaluation of the effectiveness of gabapentin in the control of renal colic pain

Comparison of the effect of gabapentin with placebo in reducing acute pain in patients with renal colic referred to Sina Hospital emergency department

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200322046833N2
Enrollment
80
Registered
2021-05-22
Start date
2021-05-22
Completion date
Unknown
Last updated
2021-05-26

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

Conditions

Acute renal colic pain. Unspecified renal colic

Interventions

Intervention 1: Intervention group: Ketorolac with a dose of 30 mg and gabapentin from Mehr Daroo Pharmaceutical Company, two capsules with a dose of 300 mg and morphine with a dose of 0.05 mg per kg

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patients aged 18-85 years with moderate to severe acute renal colic pain Obtaining informed written consent from the patient

Exclusion criteria

Exclusion criteria: History of severe kidney failure History of moderate to severe liver failure History of allergic reactions to gabapentin or its formulation components Consumption of pregabalin and gabapentin during the last week Intolerance to food Dissatisfaction with entering the study History of unknown lung disease or history of pulmonary insufficiency in COPD or fibrosis of the lung

Design outcomes

Primary

MeasureTime frame
The average pain intensity at 4 o'clock. Timepoint: Measurement of pain intensity at the time of patient admission and then every 5 minutes after drug administration and finally 4 and 8 hours after drug administration. Method of measurement: Ask the patient how much pain using the Visual Analogue Scale method.

Secondary

MeasureTime frame
The average amount of morphine consumed in each group. Timepoint: At the time of the patient's arrival and every 5 minutes after the drug is administered, morphine is added to the treatment as rescue if the pain is severe (pain above 7 out of 10). Method of measurement: Sum of the amount of morphine consumed from the moment of arrival until the patient is discharged.;Mean pain control time. Timepoint: From the moment the patient arrives until discharge. Method of measurement: From ketorolac injection to pain control below 5, no narcotics (at least 3 hours after the last narcotics) or discharge.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarhad Najmeddin

Tehran University of Medical Sciences

farhad.najm@gmail.com+98 21 6312 1402

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026