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To determine is low-dose ketorolac use in the early post-operative period (within 48 hours) provides adequate analgesia without long term adverse effect on spinal fusion rates when compared to post-operative analgesia without the use of NSAIDs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Drug: Placebo Saline 1 ml IV Q6H |
|
| Intervention | Experimental | Ketorolac 15 mg (15mg/ml) IV Q6H |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Drug | 1 ml saline IV Q6H |
| |
| Ketorolac |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion Construct X-Ray | Each fusion level will be evaluated individually and as part of the complete fusion construct. Fusion will be evaluated by blinded independent neuroradiologists using XR. | 6 months postoperatively |
| Fusion Construct X-Ray | Each fusion level will be evaluated individually and as part of the complete fusion construct. Fusion will be evaluated by blinded independent neuroradiologists using XR. | 12 months postoperatively |
| Fusion Construct X-Ray | Each fusion level will be evaluated individually and as part of the complete fusion construct. Fusion will be evaluated by blinded independent neuroradiologists using XR. | 24 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) for pain |
| Every 8 hours x 48 hours postoperatively |
| Length of Stay (LOS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doris Tong, MD | Contact | (248) 763-2380 | doris.tong@michiganspineandbrainsurgeons.com | |
| Chad Claus, DO | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Doris Tong, MD | Michigan Spine and Brain Surgeons | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence-Providence Park, Southfield | Recruiting | Southfield | Michigan | 48075 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30670528 | Derived | Claus CF, Lytle E, Tong D, Sigler D, Lago D, Bahoura M, Dosanjh A, Lawless M, Slavnic D, Kelkar P, Houseman C, Bono P, Richards B, Soo TM. The effect of ketorolac on posterior thoracolumbar spinal fusions: a prospective double-blinded randomised placebo-controlled trial protocol. BMJ Open. 2019 Jan 21;9(1):e025855. doi: 10.1136/bmjopen-2018-025855. |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Drug |
15 mg (15 mg/ml) IV Q6H |
|
-Measured in days (24 hours)
• Automatic data capture on discharge by the hospital EMR
| 12 months postoperatively |
| Morphine equivalent doses | -Non-study narcotics taken by patients on the floor are converted to morphine equivalent doses
| 12 months postoperatively |
| Complications/Adverse events | -Ketorolac-related short term in-hospital complications: GI ulceration and bleeding, GI perforation, PO bleeding, acute renal failure, anaphylactic/anaphylactoid reactions, liver failure
| 12 months postoperatively |
| Quality of life - long term | Oswestry Disability Index (ODI)
| 12 months and/or 24 months postoperatively |
| D017670 |
| Sodium Compounds |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |