Efficacy of Nefopam and Morphine in Balanced Analgesia for Acute Ureteric Colic

A Single Center, Prospective Randomized Double-blind Trial: Efficacy of Nefopam and Morphine in Balanced Analgesia for Acute Ureteric Colic

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01543165

Enrollment

111

Registered

2012-03-02

Start date

2012-12-31

Completion date

2013-12-31

Last updated

2012-12-17

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

Conditions

Renal Colic

Keywords

Renal colic, Analgesia, Nefopam, Ketorolac

Brief summary

This study is to see whether the combination regimen of ketorolac and nefopam is superior to that of ketorolac and morphine in controlling ureter stone-related acute flank pain.

Detailed description

The balanced analgesia regimen using both ketorolac and morphine is the most effective choice in controlling urolithiasis related acute pain. Previous animal and human studies reported that combination regimen of ketoprofen and nefopam showed synergistic effect in pain control. We hypothesized that using nefopam instead of morphine for ketorolac based combination analgesia will produce similar pain reduction without causing opioid-related side effect.

Interventions

DRUGKetorolac and nefopam balanced analgesia

Sequential intravenous administration of ketorolac and nefopam

DRUGBalanced analgesia using ketorolac and morphine

Sequential intravenous administration of ketorolac and morphine

DRUGPain control with single analgesics (ketorolac)

This arm do not use balanced analgesia. Instead, ketorolac IV administration followed by 50cc normal saline administration (for blinding) will be used in this group.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Acute flank with visual analog pain scale score equal or more than 5 * and most possible diagnosis after initial clinical exam is acute renal colic

Exclusion criteria

* Pregnant or lactating women * Patients whose use of any of the study drugs is contraindicated * Patients with documented renal or hepatic failure or those with clinical findings suggesting the diagnoses * Recent episode of acute myocardial infarction or patients with significant heart failure * Patients with documented gastric/duodenal ulcer or those with clinical findings suggesting the diagnoses * Patients with bleeding tendency * Patients who have history of any seizure * Patients with documented organic brain injury * Patients taking warfarin * Patients whose primary diagnosis is not renal colic

Design outcomes

Primary

Measure	Time frame
Amount of pain reduction by visual analog pain scale	At 30 and 60 minutes after primary study drug administration

Secondary

Measure	Time frame
Additional analgesia requested by enrolled patients	At 30 and 60 minutes after primary study drug administration

Countries

South Korea

Contacts

Primary ContactKyuseok Kim, MD

dremkks@snubh.org82-31-787-3049

Backup ContactJoonghee Kim, MD

joonghee@me.com82-10-9489-3696

Outcome results

None listed

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