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OpenTrials
Completed

NCT Number: NCT02181426

Dose Response of Ketorolac in Knee Arthroscopy

Ketorolac is administered as current practice to the majority of patients undergoing knee arthroscopy, the appropriate dose of ketorolac to be administered has not been evaluated.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29461, United States

About this study

Past studies have examined different doses of ketorolac administered to patients after spinal fusion surgery and found that 7.5 mg every 6 hours was as effective as 15 or 30 mg every 6 hours in decreasing postoperative pain and patient opiate consumption. Since ketorolac side effects such as gastrointestinal and surgical site bleeding seem to be dose related, utilizing a lower dose of ketorolac may be more efficacious.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Population: Patients scheduled for outpatient knee arthroscopy under general anesthesia with ASA physical status I-III ages 18-65 years old. All subjects will receive informed consent. Subjects will not be eligible to participate if they cannot provide informed consent. Non-English speaking patients will not be included due to the limited time and availability of translators.

Inclusion criteria

  • Ability to consent and desire to participate in study
  • Outpatient knee arthroscopy with Dr. C. David Geier
  • ASA physical status I-III
  • 18-65 years old
  • Over 50 kg (110 pounds)
  • General anesthesia

Exclusion criteria

  • Any contraindication to receiving a non-steroidal antiinflammatory medication (including but not limited to allergy to any non-steroidal antiinflammatory medications including aspirin; chronic renal insufficiency; history of gastric ulcers, gastritis, peptic ulcers or gastrointestinal bleeding; severe volume depletion; presence of cerebrovascular bleeding or high risk of bleeding)
  • Allergy to propofol, fentanyl or hydromorphone.
  • Any chronic painful conditions requiring opioid use for over the last 6 months
  • Emergency surgery
  • Altered mental status (not oriented to place, person or time)
  • Pregnant or lactating patients
  • Patient is taking non-steroidal antiinflammatory medications (including aspirin)1 at home and took that medication on day of surgery.
  • Non-English speaking
  • Patient refusal to study
  • Patient refusal or not a candidate for general anesthesia with Laryngeal Mask Airway (LMA)

Treatment and study plan

Ketorolac Dose

Drug

Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).

Other names: Toradol

Primary outcomes

  1. PACU Opiate Consumption

    Time frame: Less than 1 day (PACU stay in the postoperative period)

    Total PACU opioid consumption measured in intravenous morphine mg equivalents (IV MME).

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Dose Response of Ketorolac in Out-Patients Undergoing Knee Arthroscopy

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 4, 2014
Registry last updated
Sep 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.