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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06231043

Enrollment

Registered

2024-01-30

Start date

2022-04-27

Completion date

2023-04-15

Last updated

2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Colic

Keywords

Diclofenac IM versus Tramadol IV in acute renal colic, RCT

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.

Interventions

DRUGDiclofenac/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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Days to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026