NCT00845754

Brief Summary

The purpose of this study is to determine if ketorolac, given after abdominal myomectomy, will decrease the frequency of post-oerative fevers as well as improve post-operative pain management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 1999

Typical duration 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

September 1, 1999

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2001

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
Last Updated

February 18, 2009

Status Verified

February 1, 2009

Enrollment Period

1.9 years

First QC Date

February 14, 2009

Last Update Submit

February 17, 2009

Conditions

Febrile MorbidityPain

Keywords

Post-operative febrile morbidityPost-operative pain management

Outcome Measures

Primary Outcomes (1)

  • Post-operative febrile morbidity

    Inital 24hrs post-operative

Secondary Outcomes (1)

  • Post-operative pain management

    Initial 24hrs post-operative

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Drug: saline

2

ACTIVE COMPARATOR

Ketorolac

Drug: ketorolac

Interventions

ketorolacDRUG

15mg IV every6 hours for 4doses

Also known as: Toradol
2
salineDRUG

15mg IV every 6hrs for 4 doses

1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ant patient undregoing abdominal myomectomy

You may not qualify if:

  • Patients with contraindication to NSAIDs including history of peptic ulcer disease, renal disease, bleeding diathesis, or hypersensitivity to NSAIDS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pain

Interventions

KetorolacKetorolac TromethamineSodium Chloride

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV

Study Record Dates

First Submitted

February 14, 2009

First Posted

February 18, 2009

Study Start

September 1, 1999

Primary Completion

August 1, 2001

Study Completion

August 1, 2001

Last Updated

February 18, 2009

Record last verified: 2009-02

Locations

US(1)