Diclofenac IM Versus Tramadol IV in Acute Renal Colic, RCT

Last updated: January 20, 2024
Sponsor: Lampang Hospital
Overall Status: Completed

Phase

4

Condition

Colic

Kidney Stones

Acute Pain

Treatment

Diclofenac/Tramadol

Clinical Study ID

NCT06231043
100/66
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 68
Treatment Group(s): 1
Primary Treatment: Diclofenac/Tramadol
Phase: 4
Study Start date:
April 27, 2022
Estimated Completion Date:
April 15, 2023

Study Description

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

Connect with a study center

  • Lampang hospital

    Lampang, 52100
    Thailand

    Site Not Available

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