CompletedNCT00868348Updated Mar 10, 2014Results posted

A Comparison of Naropin and Ketorolac for Postoperative Analgesia After Total Knee Arthroplasty

A Phase 4 interventional study of Ketorolac and Saline in Postoperative Pain, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-10.

Sponsored by University of Aarhus · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to determine wether ketorolac is effective in the treatment of postoperative pain after total knee arthroplasty

Conditions studied

Postoperative Pain

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Pain, Postoperative 5,089

Keywords

Total Knee Arthroplasty

In context

Pain, Postoperative

5,089 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.

This study's enrollment of 60 is below the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

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

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Total knee arthroplasty
Age > 18
Tolerance for study drugs
Written informed consent

Exclusion criteria

Exclusion Criteria:

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 60 participants (actual)

Study arms

Placebo comparator
Saline
Drug: Saline
Active comparator
Ketorolac
Drug: Ketorolac

Interventions

DrugKetorolac
30 mg (1 ml) infiltration combined with Intraarticular bolus injection of 120 mg (4 ml) ketorolac
Also known as: Toradol
DrugSaline
1 ml infiltration 4 ml intraarticular bolus injection of placebo

What researchers measure

Primary outcomes

Morphine Consumption
Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery
Time frame: 48 hours after surgery

Secondary outcomes

Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request
Time frame: within 48 hours after surgery
Pain Intensity Scores During Walking
Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)
Time frame: 6-24 hours postoperatively
Home Readiness
Ability to meet discharge criteria (home readiness)
Time frame: time to fulfilment of discharge criteria
Length of Hospital Stay
Time frame: From the day of surgery until discharge
Pain Intensity During Daily Activity
Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)
Time frame: 16 weeks after surgery

Results

Posted Mar 10, 2014

Participant flow

A total of 361 patients were assessed for eligibility from May 2009 through March 2011; 62 patients participated in another study, 54 patients declined to participate, and 185 patients were excluded based on the exclusion criteria. Sixty patients (30 in each group)were enrolled, and data for the primary endpoint were registered in all patients

Participant flow — Overall Study
Milestone	Control	Ketorolac
Started	30	30
Completed	30	30
Not completed	0	0

Outcome measures

PrimaryMorphine Consumption

Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery

Time frame:: 48 hours after surgery
Reported as:: Median · mg

Morphine Consumption
mg	Control	Ketorolac
Morphine Consumption	48.75 (30 to 82.2)	10 (0 to 22.5)

SecondaryTime to First i.v. Patient Controlled Analgesia (PCA) Morphine Request

Time frame:: within 48 hours after surgery
Reported as:: Median · min

Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request
min	Control	Ketorolac
Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request	223 (115 to 319)	490 (248 to 617)

SecondaryPain Intensity Scores During Walking

Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)

Time frame:: 6-24 hours postoperatively
Reported as:: Median · mm

Pain Intensity Scores During Walking
mm	Control	Ketorolac
Pain Intensity Scores During Walking	64 (51 to 80)	29 (5 to 47)

SecondaryHome Readiness

Ability to meet discharge criteria (home readiness)

Time frame:: time to fulfilment of discharge criteria
Reported as:: Median · days

Home Readiness
days	Control	Ketorolac
Home Readiness	3 (2 to 3)	2 (2 to 3)

SecondaryLength of Hospital Stay

Time frame:: From the day of surgery until discharge
Reported as:: Median · days

Length of Hospital Stay
days	Control	Ketorolac
Length of Hospital Stay	3 (3 to 3)	3 (2 to 3)

SecondaryPain Intensity During Daily Activity

Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)

Time frame:: 16 weeks after surgery
Reported as:: Median · mm

Pain Intensity During Daily Activity
mm	Control	Ketorolac
Pain Intensity During Daily Activity	4 (1 to 21)	3 (3 to 12)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Control	—	0/30 (0%)	0/30 (0%)
Ketorolac	—	2/30 (6.7%)	0/30 (0%)

Most frequent serious events

Most frequent serious events
Event	Control	Ketorolac
HaematomaBlood and lymphatic system disorders	0/30	1/30
tachycardiaCardiac disorders	0/30	1/30

Baseline characteristics

Gender, Age,

Age, Categorical
Age, Categorical(Participants)	Control	Ketorolac	Total
<=18 years	0	0	0
Between 18 and 65 years	11	8	19
>=65 years	19	22	41

Age, Continuous
Age, Continuous(years)	Control	Ketorolac	Total
Median	71 (61 to 75)	70 (65 to 75)	71 (63 to 75)

Sex: Female, Male
Sex: Female, Male(Participants)	Control	Ketorolac	Total
Female	19	13	32
Male	11	17	28

Region of Enrollment
Region of Enrollment(participants)	Control	Ketorolac	Total
Denmark	30	30	60

Study locations

1 site

Aarhus University
Aarhus, 8000, Denmark

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00868348
Lead sponsor: University of Aarhus
Responsible party: Sponsor
First posted: Mar 25, 2009
Start date: May 2009
Primary completion: Jun 2011
Completion: Sep 2011
Results posted: Mar 10, 2014
Last update: Mar 10, 2014

Study contacts

Kjels Søballe, Professor

principal investigator · Aarhus University Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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