Pain, PostoperativePhase 2POPNCT03331315
Toradol v. Celecoxib for Postoperative Pain
A Phase 2 study testing Celecoxib and Ketorolac in people with Pain, Postoperative, run by Michael Ulm, MD at 1 site in United States.
Trial summary
Randomized control trial between ketorolac versus celecoxib for postoperative pain following hysterectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Celecoxib and Ketorolac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2013to 1 Jan 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing hysterectomy
Who cannot join
- Coronary Artery Disease
- Peptic Ulcer Disease
- Chronic Renal Disease
- Liver disease
- Alcohol Abuse
- Daily narcotic usage
Show all 21Show fewer
- Narcotic use 24 hours prior to surgery
- Crohn's Disease
- History of myocardial infarction
- History of stroke
- Preoperative hematocrit less than 24
- Asthma
- Ulcerative Colitis
- Diverticulitis
- Aspirin Allergy
- Sulfonamide Allergy
- Pre-operative pain score of greater than 3
- Patients undergoing procedures that may involve bowel resection or bowel reanastomosis.
- Allergy to any non-steroidal anti-inflammatory drug
- Cardiac anomaly or disease
- Congestive Heart Failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Trial Study of the Efficacy of Celecoxib Versus Ketorolac for Perioperative Pain Control
Randomized control trial between ketorolac versus celecoxib for postoperative pain following hysterectomy.
Read the detailed description
Purpose:
To determine if Celebrex (Celecoxib) is as effective as Toradol (Ketorolac) at controlling postoperative pain when given in addition to standard postoperative pain control regimens.
Rationale:
Toradol (Ketorolac) is currently used by many surgeons as adjuvant therapy in addition to standard narcotics in managing immediate postoperative pain. Toradol (Ketorolac) is a non-steroidal anti-inflammatory drug that acts as a non-selective cyclooxygenase (COX), inhibiting COX-1 and COX-2 isoforms. (Toradol) Ketorolac has been associated with significant complications including postoperative bleeding and acute renal insufficiency. Celebrex (Celecoxib) is a selective COX-2 inhibitor that has been associated with adverse cardiovascular outcomes in patients with pre-existing cardiac disease but not with postoperative bleeding or renal insufficiency. Celebrex (Celecoxib) has also been shown to control postoperative pain but has never been compared to Toradol (Ketorolac).
Population:
Patients undergoing hysterectomy on the gynecology oncology service.
Design:
Randomized control trial.
Procedures:
All patients will receive a standard postoperative pain regimen with oral Tylenol (Acetaminophen), oral Lortab (Hydrocodone/Acetaminophen) as needed, and IV Dilaudid (Hydromorphone) as needed.
Randomization: Each participant will be assigned a number using a random number generator for assignment to one of the two postoperative pain regimens:
Arm 1:
Patients ages 18-65 will receive IV Toradol (Ketorolac) 30mg q6 hrs after their operation for 48 hrs or until hospital discharge if patients are discharged home in less than 48 hours after their operation.
**Patients over age 65 will receive IV Toradol (Ketorolac) 15mg q6hrs instead of 30mg
Arm 2:
Patients who will receive oral Celebrex (Celecoxib) 400mg 1 hour prior to their procedure then 200mg oral twice daily for a total of seven days. Patients discharged prior to 7 days will be given a prescription for Celebrex (Celecoxib) to complete a total of 7 days.
Following surgery all patients will be given a postoperative questionnaire at the day of surgery, which was returned at the two week postoperative visit, examining time until return to ADLs, days of narcotic use, and number of narcotic pills used.
- Conditions
- Pain, Postoperative
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac | Active comparator | Patients receiving scheduled ketorolac postoperatively Receives: Drug: Ketorolac |
| Celecoxib | Experimental | Patients receiving celebrex preoperative and postoperatively for 7 days Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Inpatient Postoperative Pain Score
Pain measured using the Visual Analog Scale, no pain (0-0.4 cm), mild pain(0.5-4.4 cm), moderate pain (4.5-7.4 cm), and severe pain (7.5-10.0 cm). Subscale scoring was not used in analysis but provided as reference for patient and nursing staff.
Measured: 48 hrs following surgery
Secondary outcomes (7)
Average Inpatient Hydromorphone Use
Average inpatient hydromorphone use measured in milligrams
Measured: 48 hrs following surgery
Average Inpatient Ondansetron Use
Average inpatient ondansetron use measured in milligrams
Measured: 48 hrs following surgery
Total Hospital Stay
Total hospital stay from time fo admission to time of discharge measured in hours
Measured: Following surgery
Number of Participants With Perioperative Complications
Perioperative Complications measured intraoperatively and postoperatively by type
Measured: During and after surgery
Return to Activities of Daily Living
Average number of days required for complete return to independent activities of daily living
Measured: 2 weeks after discharge
Days of Oral Narcotic Use After Discharge
Measured using postoperative questionnaire
Measured: 2 weeks after discharge
Number of Oral Narcotic Pills Used After Discharge
Number of oral narcotic pills used after discharge until 2 week postoperative visit.
Measured: 2 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Sep 2013
- Primary completion30 Jun 2016
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Ulm, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Ulm, MD, University of Tennessee
- Investigators
- Michael A Ulm, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331315
- Sponsor's protocol ID
- 12-02041-FB
- Acronym
- POP
- Status last verified
- Nov 2023
- First submitted
- 7 Apr 2015
- Last updated
- 7 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Azari L, Santoso JT, Osborne SE. Optimal pain management in total abdominal hysterectomy. Obstet Gynecol Surv. 2013 Mar;68(3):215-27. doi: 10.1097/OGX.0b013e31827f5119.
PubMed 23945838Blanton E, Lamvu G, Patanwala I, Barron KI, Witzeman K, Tu FF, As-Sanie S. Non-opioid pain management in benign minimally invasive hysterectomy: A systematic review. Am J Obstet Gynecol. 2017 Jun;216(6):557-567. doi: 10.1016/j.ajog.2016.12.175. Epub 2016 Dec 30.
PubMed 28043841Strom BL, Berlin JA, Kinman JL, Spitz PW, Hennessy S, Feldman H, Kimmel S, Carson JL. Parenteral ketorolac and risk of gastrointestinal and operative site bleeding. A postmarketing surveillance study. JAMA. 1996 Feb 7;275(5):376-82.
PubMed 8569017Gong L, Thorn CF, Bertagnolli MM, Grosser T, Altman RB, Klein TE. Celecoxib pathways: pharmacokinetics and pharmacodynamics. Pharmacogenet Genomics. 2012 Apr;22(4):310-8. doi: 10.1097/FPC.0b013e32834f94cb. No abstract available.
PubMed 22336956
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial Study of the Efficacy of Celecoxib Versus Ketorolac for Perioperative Pain Control
- ClinicalTrials.gov ID
- NCT03331315
- Acronym / sponsor ID
- POP / 12-02041-FB
- Conditions
- Pain, Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Michael Ulm, MDUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Posted 4 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized control trial between ketorolac versus celecoxib for postoperative pain following hysterectomy.
Detailed description
Purpose:
To determine if Celebrex (Celecoxib) is as effective as Toradol (Ketorolac) at controlling postoperative pain when given in addition to standard postoperative pain control regimens.
Rationale:
Toradol (Ketorolac) is currently used by many surgeons as adjuvant therapy in addition to standard narcotics in managing immediate postoperative pain. Toradol (Ketorolac) is a non-steroidal anti-inflammatory drug that acts as a non-selective cyclooxygenase (COX), inhibiting COX-1 and COX-2 isoforms. (Toradol) Ketorolac has been associated with significant complications including postoperative bleeding and acute renal insufficiency. Celebrex (Celecoxib) is a selective COX-2 inhibitor that has been associated with adverse cardiovascular outcomes in patients with pre-existing cardiac disease but not with postoperative bleeding or renal insufficiency. Celebrex (Celecoxib) has also been shown to control postoperative pain but has never been compared to Toradol (Ketorolac).
Population:
Patients undergoing hysterectomy on the gynecology oncology service.
Design:
Randomized control trial.
Procedures:
All patients will receive a standard postoperative pain regimen with oral Tylenol (Acetaminophen), oral Lortab (Hydrocodone/Acetaminophen) as needed, and IV Dilaudid (Hydromorphone) as needed.
Randomization: Each participant will be assigned a number using a random number generator for assignment to one of the two postoperative pain regimens:
Arm 1:
Patients ages 18-65 will receive IV Toradol (Ketorolac) 30mg q6 hrs after their operation for 48 hrs or until hospital discharge if patients are discharged home in less than 48 hours after their operation.
**Patients over age 65 will receive IV Toradol (Ketorolac) 15mg q6hrs instead of 30mg
Arm 2:
Patients who will receive oral Celebrex (Celecoxib) 400mg 1 hour prior to their procedure then 200mg oral twice daily for a total of seven days. Patients discharged prior to 7 days will be given a prescription for Celebrex (Celecoxib) to complete a total of 7 days.
Following surgery all patients will be given a postoperative questionnaire at the day of surgery, which was returned at the two week postoperative visit, examining time until return to ADLs, days of narcotic use, and number of narcotic pills used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac | Active comparator | Drug: KetorolacPatients receiving scheduled ketorolac postoperatively |
| Celecoxib | Experimental | Drug: CelecoxibPatients receiving celebrex preoperative and postoperatively for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing hysterectomy
Key exclusion criteria (21 listed)
- Coronary Artery Disease
- Peptic Ulcer Disease
- Chronic Renal Disease
- Liver disease
- Alcohol Abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celecoxib | Drug | Celecoxib |
| Ketorolac | Drug | Ketorolac |
Primary outcome
Average Inpatient Postoperative Pain Score
Time frame: 48 hrs following surgery
Pain measured using the Visual Analog Scale, no pain (0-0.4 cm), mild pain(0.5-4.4 cm), moderate pain (4.5-7.4 cm), and severe pain (7.5-10.0 cm). Subscale scoring was not used in analysis but provided as reference for patient and nursing staff.
7 secondary outcomes
Average Inpatient Hydromorphone Use
Time frame: 48 hrs following surgery
Average Inpatient Ondansetron Use
Time frame: 48 hrs following surgery
Total Hospital Stay
Time frame: Following surgery
Number of Participants With Perioperative Complications
Time frame: During and after surgery
Return to Activities of Daily Living
Time frame: 2 weeks after discharge
Days of Oral Narcotic Use After Discharge
Time frame: 2 weeks after discharge
Number of Oral Narcotic Pills Used After Discharge
Time frame: 2 weeks after discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23945838Azari L, Santoso JT, Osborne SE. Optimal pain management in total abdominal hysterectomy. Obstet Gynecol Surv. 2013 Mar;68(3):215-27. doi: 10.1097/OGX.0b013e31827f5119.
- Background: PubMed 28043841Blanton E, Lamvu G, Patanwala I, Barron KI, Witzeman K, Tu FF, As-Sanie S. Non-opioid pain management in benign minimally invasive hysterectomy: A systematic review. Am J Obstet Gynecol. 2017 Jun;216(6):557-567. doi: 10.1016/j.ajog.2016.12.175. Epub 2016 Dec 30.
- Background: PubMed 8569017Strom BL, Berlin JA, Kinman JL, Spitz PW, Hennessy S, Feldman H, Kimmel S, Carson JL. Parenteral ketorolac and risk of gastrointestinal and operative site bleeding. A postmarketing surveillance study. JAMA. 1996 Feb 7;275(5):376-82.
- Background: PubMed 22336956Gong L, Thorn CF, Bertagnolli MM, Grosser T, Altman RB, Klein TE. Celecoxib pathways: pharmacokinetics and pharmacodynamics. Pharmacogenet Genomics. 2012 Apr;22(4):310-8. doi: 10.1097/FPC.0b013e32834f94cb. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Ulm, MD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib and Ketorolac in people with Pain, Postoperative, run by Michael Ulm, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Inpatient Postoperative Pain Score (time frame: 48 hrs following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03331315, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.