MedTrace Logo

Diclofenac IM Versus Tramadol IV in Acute Renal Colic, RCT

NCT06231043 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-01-30

No results posted yet for this study

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.

Conditions

  • Acute Renal Colic

Interventions

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.

Sponsors & Collaborators

  • Lampang Hospital

    lead OTHER

Principal Investigators

  • Jarupa Yaowalaorng · Lampang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-27
Primary Completion
2023-03-31
Completion
2023-04-15

Countries

  • Thailand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06231043 on ClinicalTrials.gov