NCT06231043

Diclofenac IM Versus Tramadol IV in Acute Renal Colic, RCT

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Lampang Hospital · Academic / Other
• Sex: All
• Age: 18 Days
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Acute Renal Colic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-27
• Primary completion: 2023-03-31
• Completion: 2023-04-15
• First posted: 2024-01-30
• Last updated: 2024-01-30

Locations

1 site across 1 country: Thailand