Diclofenac IM Versus Tramadol IV in Acute Renal Colic, RCT

NCT ID: NCT06231043

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-27
• Study Completion Date: 2023-04-15

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.

Conditions

Acute Renal Colic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Diclofenac/Tramadol

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Diclofenac/Tramadol

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Fenac/Tramol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lampang Hospital

OTHER

Sponsor Role: lead

Responsible Party

JARUPA YAOWALAORNG

JARUPA YAOWALAORNG

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jarupa Yaowalaorng

Role: PRINCIPAL_INVESTIGATOR

Lampang Hospital

Locations

Lampang hospital

Lampang, , Thailand

Countries

Thailand

Other Identifiers

100/66

Identifier Type: -

Identifier Source: org_study_id