An observational study in Urogynecologic Surgery, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2016-06-09.
Sponsored by University of Oklahoma · Observational
Specific Aim 1: To identify differences in pain perception and satisfaction with pain control in women undergoing urogynecologic surgery receiving nonsteroidal anti-inflammatory (NSAIDS) postoperatively by oral ibuprofen, intravenous ibuprofen, or intravenous ketorolac. Specific Aim 2: To compare the differences in narcotic usage and medication side effects.
All patient will be informed that they may receive either ibuprofen or ketorolac and that the medication may be given (IV) or per os (PO). Patients were also informed that their pain may improve or worsen during the study, and that they could request additional pain medication (as a rescue medication) at any time.
After surgery, all patients will be placed initially on a patient controlled analgesia (PCA) of hydromorphone with standardized settings of allowing the patient to dispense 0.2 mg of medication every 6 minutes (lockout rate) and an hourly maximum of 2.0 mg/hour. A one-time nursing bolus of 0.4 mg will also be ordered. The PCA will be discontinued on the morning after surgery no later than 12:00 noon. The patient will then be started on PO pain medication, either hydrocodone/acetaminophen or oxycodone/acetaminophen.
Immediately after surgery, patients will then be assigned to one of three treatment arms with a computer-generated randomization schedule that is to be based on their order of enrollment. Patients were informed they could withdraw at any point. Three visual analog scores (VAS) will be obtained from the patient before noon on the first day after surgery. One scale to assess pain at rest, one scale to assess pain with ambulation, and one scale to assess satisfaction with pain control.
The medications will each be given every 8 hours in order to keep all medications on a similar doing regimen. This will allow the patients to receive a total of three doses of medication over 24 hours, regardless of which arm of the study they are randomized to.
University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects will be recruited and consented through an IRB-approved process. Women and minorities are included in the research protocol. We will not exclude potential subjects from participating in this or any study solely on the basis of ethnic origin or socioeconomic status. There are no children involved in this study.
Exclusion Criteria:
Pain scores
Three visual analog scores (VAS) will be obtained from the patient before noon on the first day after surgery. One scale to assess pain at rest, one scale to assess pain with ambulation, and one scale to assess satisfaction with pain control.
Time frame: Within 24 hours after surgery
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University of Oklahoma