Diclofenac IM Versus Tramadol IV in Acute Renal Colic, RCT

NCT06231043 | Completed Phase 4 DMC

• 1 other identifier: 100/66
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Renal Colic

Keywords

Diclofenac IM versus Tramadol IV in acute renal colic, RCT

Outcome Measures

Primary Outcomes (1)

• Diclofenac 75 mg IM or Tramadol 50 mg IV

  Time to pain relief

  30,60,90,120 minutes

Study Arms (2)

Drug1

EXPERIMENTAL

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

Drug: Diclofenac/Tramadol

Drug2

ACTIVE COMPARATOR

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.

Drug: Diclofenac/Tramadol

Interventions

Diclofenac/Tramadol 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.

Also known as: Fenac/Tramol

Drug1; Drug2

Eligibility Criteria

• Age: 18 Days+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Acute pain in renal/ureteric colic
• Pain score more than 4
• Confirmation diagnosis by ultrasound bedside

You may not qualify if:

• Refused to participate in the research
• Pregnancy
• Contraindicated of Diclofenac or Tramadol
• Urinary tract infection
• Skin infection at Buttock area
• Acute kidney injury
• CKD stage III, IV, V
• Bilateral severe hydronephrosis
• Physician refusal

Sponsors & Collaborators

• Lampang Hospital: lead

Study Sites (1)

Lampang hospital

Lampang, 52100, Thailand

Location

MeSH Terms

Conditions

Renal Colic

Interventions

Diclofenac; Tramadol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Jarupa Yaowalaorng

  Lampang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: JARUPA YAOWALAORNG

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: January 30, 2024
• Study Start: April 27, 2022
• Primary Completion: March 31, 2023
• Study Completion: April 15, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)