Diclofenac IM Versus Tramadol IV in Acute Renal Colic, RCT

January 20, 2024 updated by: JARUPA YAOWALAORNG, Lampang Hospital

Comparative Efficacy of Intramuscular Diclofenac Injection Versus Intravascular Tramadol Injection in Acute Renal Colic, a Randomized Controlled Trial

Patients presented with acute pain from renal colic, the standard of care are prescribed NSAIDs, most common drug used is intramuscular (IM) Diclofenac injected at the gluteal muscle. Due to adverse effects in some patients, the nursing council has banned the injection by nurses. Since then, there has been a change in treatment by using intravascular (IV) Tramadol. According to various research, Diclofenac has a higher efficacy in controlling pain compared to other medications. In clinical practice, Tramadol has less efficacy of decreasing pain and a longer onset of action. At presence, there has been no research performed comparing the efficacy between these two drugs especially from the viewpoint of time dimension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To compare the efficacy Diclofenac 75 mg IM versus Tramadol 50 mg IV in patients with acute pain from renal colic.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Lampang, Thailand, 52100
        • Lampang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age over 18 years
  2. Acute pain in renal/ureteric colic
  3. Pain score more than 4
  4. Confirmation diagnosis by ultrasound bedside

Exclusion Criteria:

  1. Refused to participate in the research
  2. Pregnancy
  3. Contraindicated of Diclofenac or Tramadol
  4. Urinary tract infection
  5. Skin infection at Buttock area
  6. Acute kidney injury
  7. CKD stage III, IV, V
  8. Bilateral severe hydronephrosis
  9. Physician refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug1
Diclofenac 75 mg (3 ml) IM injection by doctor, then followed by normal saline 20 ml IV injection (equal to Tramadol diluted) by nurse.
Drug: Diclofenac/Tramadol

Arm Drug1 :Diclofenac 75 mg (3 ml) IM injection by doctor, then followed by normal saline 20 ml IV injection (equal to Tramadol diluted) by nurse.

Arm Drug2 :Normal saline 3 ml IM injection by doctor (equal to Diclofenac 75 mg), then followed by Tramadol 50 mg (1 ml) dilute with normal saline 19 ml (total 20 ml )IV injection by nurse.

Other Names:
  • Fenac/Tramol
Active Comparator: Drug2
Normal saline 3 ml IM injection by doctor (equal to Diclofenac 75 mg), then followed by Tramadol 50 mg (1 ml) dilute with normal saline 19 ml (total 20 ml )IV injection by nurse.
Drug: Diclofenac/Tramadol

Arm Drug1 :Diclofenac 75 mg (3 ml) IM injection by doctor, then followed by normal saline 20 ml IV injection (equal to Tramadol diluted) by nurse.

Arm Drug2 :Normal saline 3 ml IM injection by doctor (equal to Diclofenac 75 mg), then followed by Tramadol 50 mg (1 ml) dilute with normal saline 19 ml (total 20 ml )IV injection by nurse.

Other Names:
  • Fenac/Tramol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diclofenac 75 mg IM or Tramadol 50 mg IV
Time Frame: 30,60,90,120 minutes
Time to pain relief
30,60,90,120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lampang Hospital

Investigators

  • Principal Investigator: Jarupa Yaowalaorng, Lampang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2022

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

April 15, 2023

Study Registration Dates

First Submitted

January 20, 2024

First Submitted That Met QC Criteria

January 20, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 20, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100/66

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Personal reasons

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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