Diclofenac IM Versus Tramadol IV in Acute Renal Colic, RCT

Lampang Hospital

Status and phase: Completed; Phase 4

Conditions: Acute Renal Colic

Treatments: Drug: Diclofenac/Tramadol

Study type: Interventional

Funder types: Other

Identifiers

NCT06231043

100/66

Details and patient eligibility

About

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.

Full description

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

Enrollment: 68 patients

Sex: All

Ages: 18+ days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups

Drug1

Experimental group

Description:

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

Treatment:

Drug: Diclofenac/Tramadol

Drug2

Active Comparator group

Description:

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.

Treatment:

Drug: Diclofenac/Tramadol