Diclofenac IM Versus Tramadol IV in Acute Renal Colic, RCT

Acute Renal Colic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06231043
• Other study ID #: 100/66
• Status: Completed
• Phase: Phase 4
• Start date: April 27, 2022
• Est. completion date: April 15, 2023

Study information

• Verified date: January 2024
• Source: Lampang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 15, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Days and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Renal Colic
• Colic
• Renal Colic

Intervention

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.

Locations

Country	Name	City	State
Thailand	Lampang hospital	Lampang

Sponsors (1)

Lead Sponsor	Collaborator
Lampang Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diclofenac 75 mg IM or Tramadol 50 mg IV	Time to pain relief	30,60,90,120 minutes