NCT07176572

Brief Summary

The aim of this study was to compare the analgesic efficacy of transcutaneous electrical nerve stimulation (TENS) and dexketoprofen trometamol in patients presenting to the emergency department due to renal colic.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for phase_4

Timeline
8mo left

Started Mar 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

September 10, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

September 10, 2025

Last Update Submit

September 29, 2025

Conditions

Renal Colic

Keywords

Transcutaneous electrical nerve stimulationemergency medicineDexketoprofen Trometamol

Outcome Measures

Primary Outcomes (1)

  • Change of the intensity of pain

    Pain intense will be measured by 100 mm visual analog scale (Zero; no pain and 100 mm; the worst pain) after 15th and 30th minutes later the administration of the study interventions

    15 minutes and 30 minutes after the administration of the study interventions

Secondary Outcomes (2)

  • Adverse events

    30 minutes after

  • need to rescue medication

    30 minutes after

Study Arms (2)

Real Transcutaneous electrical nerve stimulation (TENS)

EXPERIMENTAL

Patients receiving the real transcutaneous electrical nerve stimulation (TENS) with 100 hertz, pulse width 200 microseconds, voltage 2 milliampere

Device: TENS

dexketoprofen trometamol

ACTIVE COMPARATOR

50 mg dexketoprofen trometamol

Drug: Dexketoprofen Trometamol

Interventions

TENSDEVICE

Transcutaneous electrical nerve stimulation (TENS) treatment will be activated + NS IV Infusion 100 ml

Also known as: Comfort plus TENS device
Real Transcutaneous electrical nerve stimulation (TENS)
Dexketoprofen TrometamolDRUG

50 mg dexketoprofen trometamol in 100 ml normal saline solution + Transcutaneous electrical nerve stimulation treatment will not be activated.

Also known as: Ketavel (dexketoprofen trometamol)
dexketoprofen trometamol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Aged 18 years or over with a definite diagnosis of renal colic

You may not qualify if:

  • Patients who refuse to participate in the study
  • Pregnant women
  • Breastfeeding women
  • Haemodynamically unstable
  • Evidence of peritoneal inflammation
  • Patients who were taking analgesics at the time of initial presentation
  • Unconsciousness or inability to communicate
  • Contraindications to applying TENS or using the drug in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adiyaman University Medical Faculty

Adıyaman, Turkey (Türkiye)

Location

Related Publications (3)

  • Gulacti U, Algin A, Turgut K, Yavuz E, Aydin I, Buyukaslan H, Lok U, Arslan E, Gonel A. Transcutaneous Electrical Nerve Stimulation (TENS) for the Treatment of Renal Colic in the ED: A Randomized, Double-Blind, Placebo-Controlled Trial. Am J Emerg Med. 2022 Jun;56:127-132. doi: 10.1016/j.ajem.2022.02.044. Epub 2022 Mar 29.

    PMID: 35397352BACKGROUND

  • Al B, Sunar MM, Zengin S, Sabak M, Bogan M, Can B, Kul S, Murat Oktay M, Eren SH. Comparison of IV dexketoprofen trometamol, fentanyl, and paracetamol in the treatment of renal colic in the ED: A randomized controlled trial. Am J Emerg Med. 2018 Apr;36(4):571-576. doi: 10.1016/j.ajem.2017.09.019. Epub 2017 Sep 14.

    PMID: 29029797BACKGROUND

  • Hanna M, Moon JY. A review of dexketoprofen trometamol in acute pain. Curr Med Res Opin. 2019 Feb;35(2):189-202. doi: 10.1080/03007995.2018.1457016. Epub 2018 Apr 24.

    PMID: 29569951BACKGROUND

MeSH Terms

Conditions

Renal Colic

Interventions

Transcutaneous Electric Nerve Stimulationdexketoprofen trometamol

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Umut Gulacti, Prof.Dr.

    Adiyaman University of Medical Faculty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Umut Gulacti, Prof.Dr.

CONTACT

+905355851900umutgulacti@gmail.com

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
Professor

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 16, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09

Locations

TU(1)