Diclofenac IM Versus Tramadol IV in Acute Renal Colic, RCT

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.

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Key information

Conditions

Acute Renal Colic Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Renal Colic Signs and Symptoms

Age range

18 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lampang hospital

Lampang, 52100, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Refused to participate in the research
Pregnancy
Contraindicated of Diclofenac or Tramadol
Urinary tract infection
Skin infection at Buttock area
Acute kidney injury
CKD stage III, IV, V
Bilateral severe hydronephrosis
Physician refusal

Treatment and study plan

Diclofenac/Tramadol

Drug

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

Primary outcomes

Diclofenac 75 mg IM or Tramadol 50 mg IV

Time frame: 30,60,90,120 minutes

Time to pain relief

Sponsors and collaborators

Lead sponsor

Lampang Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jan 30, 2024
Registry last updated: Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed