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Submitted: 06 Apr 2025
Revision: 17 Jun 2025
Accepted: 18 Jun 2025
ePublished: 22 Jun 2025
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J Nephropharmacol. 2025;14(2): e12774.
doi: 10.34172/npj.2025.12774
  Abstract View: 32
  PDF Download: 21

Clinical Trial

Comparison the clinical efficacy of intravenous fentanyl and ketorolac in relieving renal colic pain; a controlled randomized clinical trial

Davood Arab 1,2 ORCID logo, Arash Ardestanizadeh 1,2 ORCID logo, Reihane Ghanipour 2, Majid Mirmohammadkhani 3 ORCID logo, Mohammadreza Moonesan 2,4* ORCID logo

1 Department of Surgery, Kowsar Hospital, Semnan University of Medical Sciences, Semnan, Iran
2 Clinical Research Development Center, Kowsar Hospital, Semnan University of Medical Sciences, Semnan, Iran
3 Social Determinants of Health Research Center, Department of Epidemiology and Biostatistics, School of Medicine, Semnan University of Medical Sciences, Semnan, Iran
4 Department of Emergency Medicine, School of Medicine, Semnan University of Medical Sciences, Semnan, Iran
*Corresponding Author: Mohammadreza Moonesan, Email: mohammad.reza5332@gmail.com

Abstract

Introduction: Renal colic pain is due to increased pressure on the wall of the urinary tract and is caused by the passage of a stone through the urinary tract. Although most kidney stones are eliminated spontaneously, rapid relief of the patient’s pain is an important issue in the acute phase.

Objectives: This study aimed to compare the effect of intravenous ketorolac and intravenous fentanyl in relieving pain in patients with renal colic.

Patients and Methods: In a randomized controlled clinical trial, 110 patients who were referred to the emergency department for renal colic were randomly divided into two groups using the randomized block method. One group received intravenous fentanyl at a dose of 0.1 mg, and the other group received intravenous ketorolac at a dose of 30 mg. Vital signs and pain level of the patients were recorded using the Visual Analogue Scale (VAS) before drug injection and at 20, 40, and 60 minutes after injection. The results were compared between the two groups.

Results: No significant difference was found in initial pain intensity between the two groups. Furthermore, pain intensity after the intervention did not significantly differ between the groups at 20, 40, and 60 minutes. Additionally, there was no significant difference in the reduction of pain intensity between the two study groups (P=0.959). Both interventions effectively reduced patients’ pain with a similar pattern over time. There was no significant difference in pulse rate and respiratory rate between the two groups after the intervention. The incidence of blood pressure reduction was significantly lower in the group that received fentanyl (P<0.001), however the frequency of other complications was not significantly different between the two groups.

Conclusion: Both intravenous ketorolac and fentanyl were equally effective in relieving pain in patients with renal colic, showing similar pain reduction patterns over 60 minutes. While both interventions had comparable effects on pulse and respiratory rates, fentanyl was associated with a significantly lower incidence of blood pressure reduction. Our findings suggest that both drugs are effective for acute renal colic pain, with fentanyl potentially offering a more favorable cardiovascular profile.

Trial Registration: The trial protocol was approved in the Iranian registry of clinical trial (identifier: IRCT20150902023855N3; https://irct.behdasht.gov.ir/trial/31789, ethical code; IR.SEMUMS. REC.1399.067).


Implication for health policy/practice/research/medical education:

This randomized clinical trial study provides valuable evidence for management of acute renal colic pain. Clinically, the findings support the use of either intravenous ketorolac or intravenous fentanyl as effective first-line agents, demonstrating comparable efficacy and speed of pain relief, thus offering flexibility based on availability or patient-specific factors. This evidence can be conducted to endorse guidelines that include both options for emergency departments. However, the significantly lower incidence of hypotension observed with fentanyl compared to ketorolac is a crucial consideration for clinical practice and medical education, guiding drug selection particularly in patients at risk for hemodynamic instability. Medical education curricula should emphasize the equivalent analgesic efficacy while highlighting this difference in side effect profiles. Further research could explore cost-effectiveness, patient satisfaction, the need for rescue analgesia with each agent, and their comparative efficacy and safety in specific patient subpopulations (e.g., elderly, patients with comorbidities).

Please cite this paper as: Arab D, Ardestanizadeh A, Ghanipour R, Mirmohammadkhani M, Moonesan M. Comparison the clinical efficacy of intravenous fentanyl and ketorolac in relieving renal colic pain; a controlled randomized clinical trial. J Nephropharmacol. 2025;14(2):e12774 DOI: 10.34172/npj.2025.12774.

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