NCT02937896

Brief Summary

The aim of this study is the comparison of efficacy of intravenous ketorolac and intranasal desmopressin in renal colic patients pain control.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

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

January 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

1.1 years

First QC Date

October 12, 2016

Last Update Submit

October 18, 2016

Conditions

Renal Colic

Outcome Measures

Primary Outcomes (1)

  • Pain score

    Pain score change from baseline pain score before intervention 10, 30 and 60 minutes after intervention

Study Arms (2)

Ketorolac

EXPERIMENTAL

30mg ketorolac administrated intravenous and 4 puffs nasal Normal Saline.

Drug: KetorolacDrug: Normal Saline

Desmopressin

ACTIVE COMPARATOR

40 microgram nasal desmopressin administrated and 1cc Normal Saline intravenous

Drug: DesmopressinDrug: Normal Saline

Interventions

DesmopressinDRUG

40 micrograms Nasal Desmopressin.

Also known as: Ddavp
Desmopressin
KetorolacDRUG

30mg intravenous Ketorolac.

Also known as: Toradol
Ketorolac
Normal SalineDRUG

1cc intravenous Normal Saline.

Also known as: NaCl
Desmopressin

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • renal colic patients

You may not qualify if:

  • history of hypertension and cardiac disease
  • pregnant patients
  • use of analgesic within 4 hours before intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Colic

Interventions

Deamino Arginine VasopressinKetorolacKetorolac TromethamineSaline Solution

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arginine VasopressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency Medicine Resident

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 19, 2016

Study Start

January 1, 2015

Primary Completion

February 1, 2016

Study Completion

April 1, 2016

Last Updated

October 19, 2016

Record last verified: 2016-10