NCT00504283

Brief Summary

An analgesia protocol for acute renal colic will lead to faster significant reductions in pain than prior practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

October 18, 2007

Status Verified

October 1, 2007

First QC Date

July 17, 2007

Last Update Submit

October 17, 2007

Conditions

Kidney Stone

Keywords

Renal colic, pain, protocol, emergency department

Outcome Measures

Primary Outcomes (1)

  • Time to significant pain relief

    Within emergency department

Interventions

ToradolDRUG
MorphineDRUG

Eligibility Criteria

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

You may qualify if:

  • Kidney stone on stone protocol CT scan
  • Acute pain from a kidney stone

You may not qualify if:

  • Age \< 18 or \> 65
  • Pregnant women
  • Contraindications to NSAID's or opiates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHMC

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Kidney CalculiRenal ColicPainEmergencies

Interventions

Ketorolac TromethamineMorphine

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Peter L Steinberg, MD

    DHMC dept of Urology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 19, 2007

Study Start

February 1, 2007

Study Completion

October 1, 2007

Last Updated

October 18, 2007

Record last verified: 2007-10

Locations

US(1)