MedDataX Logo

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

NCT ID: NCT01543165

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Colic

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Renal colic Analgesia Nefopam Ketorolac

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Sequential intravenous administration of ketorolac and nefopam

Group Type EXPERIMENTAL

Ketorolac and nefopam balanced analgesia

Intervention Type DRUG

Sequential intravenous administration of ketorolac and nefopam

Group 2

Sequential intravenous administration of ketorolac and morphine

Group Type ACTIVE_COMPARATOR

Balanced analgesia using ketorolac and morphine

Intervention Type DRUG

Sequential intravenous administration of ketorolac and morphine

Group 3

Intravenous administration of ketorolac

Group Type PLACEBO_COMPARATOR

Pain control with single analgesics (ketorolac)

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketorolac and nefopam balanced analgesia

Sequential intravenous administration of ketorolac and nefopam

Intervention Type DRUG

Balanced analgesia using ketorolac and morphine

Sequential intravenous administration of ketorolac and morphine

Intervention Type DRUG

Pain 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pharmbio Korea

UNKNOWN

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Bundang Hospital

Seongnam-si, Kyeongi-do, South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kyuseok Kim, MD

Role: CONTACT

Phone: 82-31-787-3049

Email: [email protected]

Joonghee Kim, MD

Role: CONTACT

Phone: 82-10-9489-3696

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kyuseok Kim, MD

Role: primary

Joonghee Kim, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B-1112/141-011

Identifier Type: -

Identifier Source: org_study_id