CompletedNCT02181426Updated Sep 21, 2018Results posted

Dose Response of Ketorolac in Knee Arthroscopy

An interventional study of Ketorolac Dose in Meniscectomy, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-21.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 112
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

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.

Read the detailed description

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.

Conditions studied

Meniscectomy

Keywords

Knee Arthroscopy

In context

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

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

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

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)

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Care provider)
Enrollment: 112 participants (actual)

Study arms

Placebo comparator
0 mg of Ketorolac
participant receives 0 mg of Ketorolac
Drug: Ketorolac Dose
Active comparator
7.5 mg of Ketorolac
participant receives 7.5 mg of Ketorolac
Drug: Ketorolac Dose
Active comparator
15 mg Ketorolac
participant receives 15 mg of Ketorolac
Drug: Ketorolac Dose
Active comparator
30 mg Ketorolac
participant receives 30mg of Ketorolac
Drug: Ketorolac Dose

Interventions

DrugKetorolac Dose
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).
Also known as: Toradol

What researchers measure

Primary outcomes

PACU Opiate Consumption
Total PACU opioid consumption measured in intravenous morphine mg equivalents (IV MME).
Time frame: Less than 1 day (PACU stay in the postoperative period)

Results

Posted Jun 8, 2018

Participant flow

Participant flow — Overall Study
Milestone	0 mg of Ketorolac	7.5 mg of Ketorolac	15 mg Ketorolac	30 mg Ketorolac
Started	28	28	28	28
Completed	28	28	28	28
Not completed	0	0	0	0

Outcome measures

PrimaryPACU Opiate Consumption

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

Time frame:: Less than 1 day (PACU stay in the postoperative period)
Reported as:: Mean · IV Morphine Equivalents (mg)

PACU Opiate Consumption
IV Morphine Equivalents (mg)	0 mg of Ketorolac	7.5 mg of Ketorolac	15 mg Ketorolac	30 mg Ketorolac
PACU Opiate Consumption	7.7 ± 0.86	6.3 ± 0.86	6.5 ± 0.86	5.0 ± 0.86

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
0 mg of Ketorolac	—	0/28 (0%)	0/28 (0%)
7.5 mg of Ketorolac	—	0/28 (0%)	0/28 (0%)
15 mg Ketorolac	—	0/28 (0%)	0/28 (0%)
30 mg Ketorolac	—	0/28 (0%)	0/28 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	0 mg of Ketorolac	7.5 mg of Ketorolac	15 mg Ketorolac	30 mg Ketorolac	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	28	28	28	28	112
>=65 years	0	0	0	0	0

Age, Continuous
Age, Continuous(Years)	0 mg of Ketorolac	7.5 mg of Ketorolac	15 mg Ketorolac	30 mg Ketorolac	Total
Mean	49.4 ± 11.9	44.2 ± 12.7	44.7 ± 14.2	44.4 ± 13	45.7 ± 13.0

Sex: Female, Male
Sex: Female, Male(Participants)	0 mg of Ketorolac	7.5 mg of Ketorolac	15 mg Ketorolac	30 mg Ketorolac	Total
Female	14	8	15	12	49
Male	14	20	13	16	63

Region of Enrollment
Region of Enrollment(Participants)	0 mg of Ketorolac	7.5 mg of Ketorolac	15 mg Ketorolac	30 mg Ketorolac	Total
United States	28	28	28	28	112

Study locations

1 site

Medical University of South Carolina
Charleston, South Carolina 29461, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02181426
Lead sponsor: Medical University of South Carolina
Responsible party: Sponsor
First posted: Jul 4, 2014
Start date: Mar 2012
Primary completion: Dec 15, 2016
Completion: Dec 15, 2016
Results posted: Jun 8, 2018
Last update: Sep 21, 2018

Study contacts

Sylvia H Wilson, MD

principal investigator · Medical University of South Carolina

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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