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Purpose and Brief Explanation of Study:
Tapentadol is a unique medication that treats pain through its effects at the opioid receptor and due to serotonin and norepinephrine reuptake inhibition. These have been thought to result in increased relief of pain with a decreased use of other medications and decreased side effects compared with other drugs commonly used to treat pain in people. This study will determine if tapentadol causes relief of pain when given by mouth to dogs experiencing pain. These results will provide veterinarians with essential information for tapentadol dosing to treat pain in dogs. This knowledge should help veterinarians address both acute and chronic pain.
Which patients are eligible to participate in this clinical trial?
Dogs of any breed, age, or sex must meet the following criteria:
- Dog must weigh at least 20 kg (44lbs)
- Be presented for single leg lameness caused by osteoarthritis
- Be otherwise healthy
- Not on Tramadol or medication to address behavioral issues (e.g. trazodone)
- No food allergies
- Owner consent for study participation
What are the exclusion criteria?
Dogs will be excluded from the study if they are less than 20 kg, have bilateral lameness or lameness associated with a condition other than osteoarthritis, on tramadol or other behavior modification drugs, are not otherwise healthy based on physical exam and blood work evaluation, or have food allergies that prohibit consumption of the food administered with the medication.
What will happen if my dog participates in this clinical trial?
Once your dog has been deemed eligible to enter the study, he/she will be walked across a pressure-sensitive walkway and current pain status will be evaluated. Dogs will then receive a pain medication orally with food. After the drug has taken effect, (within 4-6 hours) he/she will be walked across a pressure-sensitive walkway again and pain status will be re-evaluated. A blood sample will be collected and the dog is discharged from the study.
What side effects or risks may my dog experience while participating in this clinical trial?
Nausea and vomiting have been reported following tapentadol administration in dogs. These side effects are generally transient and well controlled with standard appropriate medications. There are no other known side effects.
Can my dog withdraw from the clinical trial?
You may decide to withdraw your dog from the clinical trial at any time.
Additionally, your dog may be removed from the study at any time if we believe it is in your dog’s best interest, or if the trial is discontinued or if the trial protocol is not followed.
What are my responsibilities during the clinical trial?
You are responsible for the cost of surgery, anesthesia, housing, blood tests, and medications, and care associated with your dog’s surgery.
What financial incentives will be provided for my dog’s participation?
Clients participating in this study will be given a one-time credit of $250 that can be applied towards the costs associated with the surgical management of your dog’s condition at The Ohio State University Veterinary Medical Center. If you decide to withdraw your dog from the study prior to study completion, this credit will not be applied to your account. However, if your dog is removed from the study by one of the study investigators due to medical concerns as it is believed to be in the best interest of your dog, then you will still receive the credit.
Turi Aarnes, DVM, MS, DACVA (email@example.com) or the Clinical Trials Office at the Veterinary Medical Center for more information about this study.