NCT01543165

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
111

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

February 27, 2012

Last Update Submit

December 13, 2012

Conditions

Renal Colic

Keywords

Renal colicAnalgesiaNefopamKetorolac

Outcome Measures

Primary Outcomes (1)

  • Amount of pain reduction by visual analog pain scale

    At 30 and 60 minutes after primary study drug administration

Secondary Outcomes (1)

  • Additional analgesia requested by enrolled patients

    At 30 and 60 minutes after primary study drug administration

Study Arms (3)

Group 1

EXPERIMENTAL

Sequential intravenous administration of ketorolac and nefopam

Drug: Ketorolac and nefopam balanced analgesia

Group 2

ACTIVE COMPARATOR

Sequential intravenous administration of ketorolac and morphine

Drug: Balanced analgesia using ketorolac and morphine

Group 3

PLACEBO COMPARATOR

Intravenous administration of ketorolac

Drug: Pain control with single analgesics (ketorolac)

Interventions

Ketorolac and nefopam balanced analgesiaDRUG

Sequential intravenous administration of ketorolac and nefopam

Group 1
Balanced analgesia using ketorolac and morphineDRUG

Sequential intravenous administration of ketorolac and morphine

Group 2
Pain control with single analgesics (ketorolac)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.

Group 3

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Kyeongi-do, South Korea

RECRUITING

MeSH Terms

Conditions

Renal ColicAgnosia

Interventions

KetorolacMorphineAnalgesiaAnalgesics

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAnesthesia and AnalgesiaSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic Uses

Central Study Contacts

Kyuseok Kim, MD

CONTACT

82-31-787-3049dremkks@snubh.org

Joonghee Kim, MD

CONTACT

82-10-9489-3696joonghee@me.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 2, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations

KR(1)