Diclofenac IM Versus Tramadol IV in Acute Renal Colic, RCT

Phase 4

Completed

• Conditions: Acute Renal Colic
• Interventions: Drug: Diclofenac/Tramadol

• Registration Number: NCT06231043
• Lead Sponsor: Lampang Hospital

Brief 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.

Study Timeline

• Study Start: 2022-04-27
• Primary Completion: 2023-03-31
• Study Completion: 2023-04-15
• Status Verified: 2024-01
• Study First Submitted: 2024-01-20
• Study First Submitted QC: 2024-01-20
• Last Update Submitted: 2024-01-20
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug1	Diclofenac/Tramadol	Diclofenac 75 mg (3 ml) IM injection by doctor, then followed by normal saline 20 ml IV injection (equal to Tramadol diluted) by nurse.
Drug2	Diclofenac/Tramadol	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.

Primary Outcome Measures

Name	Time	Method
Diclofenac 75 mg IM or Tramadol 50 mg IV	30,60,90,120 minutes	Time to pain relief

Trial Locations

Locations (1)

Lampang hospital; 🇹🇭 Lampang, Thailand