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Status unknownNCT01514175Updated May 16, 2012

A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac

A Phase 4 interventional study of IV Ibuprofen and IV Ketorolac in Chronic Pelvic Pain, sponsored by Culpeper Surgery Center. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-05-16.

Sponsored by Culpeper Surgery Center · Phase 4, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified May 2012), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).

Read the detailed description

The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).

The secondary objectives of this study are:

  • To compare amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
  • To compare time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
  • To compare time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
  • To compare the incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups.
02

Conditions studied

  • Chronic Pelvic Pain

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Keywords

  • Ketorolac
  • Caldolor
  • Chronic Pelvic Pain
03

In context

Pelvic Pain

375 studies on the registry are indexed under Pelvic Pain; 83 are open to participants now.

This study's enrollment of 50 is close to the median of 54 across 273 interventional studies indexed under Pelvic Pain.

Browse Pelvic Pain studies →

Lead sponsor

This is the only study on the registry with Culpeper Surgery Center as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with a preoperative diagnosis which is inclusive of chronic pelvic pain scheduled for Laparoscopic Surgery

Exclusion criteria

Exclusion Criteria:

  • Inadequate IV access.
  • History of allergy or hypersensitivity to any component of IVIb,ketorolac, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors.
  • Less than 18 years of age or Greater than 65 years of age.
  • Use of analgesics, including NSAIDs, less than 12 hours prior to surgery.
  • Patients with active, clinically significant anemia.
  • History or evidence of asthma or heart failure.
  • Pregnant.
  • Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions and to return for the required assessments.
  • Refusal to provide written authorization for use and disclosure of protected health information.
  • Patients with a history of Chronic Pain Conditions or Syndromes excluding patients with Chronic Pelvic Pain.
  • Patients with known OSA
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    ibuprofen versus ketoralac

    IV ibuprofen (800 mg intravenous ibuprofen administered intravenously over 10 minutes) will be administered as a single dose prior to surgery at the initiation of anesthesia. A corresponding volume of NS will be administered to the group randomized to ketorolac, at the same time to maintain the study blind.

    Drug: IV Ibuprofen · Drug: IV Ketorolac

Interventions

  • DrugIV Ibuprofen

    Patients will be randomized to receive 800 mg intravenous ibuprofen or 30 mg ketorolac; each of the two treatment groups will consist of 25 patients.

    Also known as: IV Caldolor

  • DrugIV Ketorolac

    Patients will be randomized to receive 800 mg intravenous ibuprofen or 30 mg ketorolac; each of the two treatment groups will consist of 25 patients.

    Also known as: IV Toradol

06

What researchers measure

Primary outcomes

  1. The efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).

    Time frame: One Year

Secondary outcomes

  1. Amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups

    Time frame: 1 Year

  2. Time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups

    Time frame: One Year

  3. Time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups

    Time frame: One Year

  4. Incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups

    Time frame: One Year

07

Study locations

1 site
  • Culpeper Surgery Center
    Culpeper, Virginia 22701, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01514175
Lead sponsor
Culpeper Surgery Center
Collaborators
Cumberland Pharmaceuticals
Responsible party
Khalid Athar M.D. (Medical Director, Culpeper Surgery Center) — Principal investigator
First posted
Jan 23, 2012
Start date
Jan 2012
Primary completion
Dec 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
May 16, 2012

Study contacts

Khalid Athar, MD
principal investigator · Culpeper Regional Health Systems

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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