Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure
Ključne riječi
Sažetak
Opis
A prospective, double blind, randomized controlled trial evaluating the effects of two new IV medications, IV ibuprofen and IV acetaminophen, on standard of care pain and anti-emetic management in Uterine Fibroid Embolization patients.
1. Four arm, double blind, randomized controlled study: all patients will receive standard of care baseline pain medications, including IV midazolam, fentanyl and hydromorphone during the procedure, followed by a hydromorphone PCA infusion pump during their recovery. The four arms will include an IV ibuprofen/IV placebo, an IV acetaminophen/IV placebo, an IV ibuprofen/IV acetaminophen, and a control arm (IV placebo/IV placebo). The same amount of normal saline will be substituted for the experimental treatments if the patient receives the placebo. These medications will be given during the procedure and extended over a 24 hour recovery period. The medications given will be blinded to the patient, the administrator, and the surveyor.
2. The placebo/placebo arm would replicate current standard of care, and therefore include IV push (IVP) ketorolac, which would be given at the end of the procedure and be continued for 24 hours at q6hour dosing. An IVP of saline would be given as a control for 24 hours at q6hour dosing to the other three arms.
3. Dosage of medications will be standardized based on formulary indications: IV Ketorolac 30 mg/dose IVP, acetaminophen 1 gram/dose IV piggy back over 15 minutes every 6 hours, ibuprofen 800 mg/dose IV piggy back over 30 minutes every 6 hours.
4. Variables measured: mean and maximum pain (VAS score at 0 hours, 6 hours, discharge and 2 weeks post procedure), opioid requirements, mean and maximum nausea (VAS score at 0 hours, 6 hours, discharge and 2 weeks post procedure), anti-emetic medication requirements.
Weighted sum of pain intensity differences, with pain intensity measured on VAS over 24 hours (SPID24) will be used as a primary outcome. Satisfaction scores will be measured at 24 hours using the validated APS-POQ-R questionnaire (6).
5. Other variables recorded: Age, height, weight, history of postoperative nausea and vomiting or motion sickness, diagnosis, uterine volume, dominant fibroid size, arteries embolized, presence of prominent ovarian arteries, volume of particle used, fluoroscopy time for the procedure.
6. Technical parameters, which would remain constant, include: pre procedure and 6 month follow up MRI contrast with gadolinium which is standard of care, embolization using 500-700 micron Embospheres (with limited use of 700-900 micron Embospheres), IV hydration with 0.9% normal saline, antibiotics (IV ciprofloxacin 400 mg every 12 hours, IV metronidazole 500 mg every six hours), urinary catheter placement, lower extremity compression devices, and early ambulation.
7. In the interim analysis, the investigators will have 40 subjects in total with unequal randomization ratio of 1:1:4:4. Additional subjects will be enrolled for a total of 35 subjects per arm for the final analysis (sum total N=140)
Datumi
Posljednja provjera: | 05/31/2018 |
Prvo podneseno: | 08/25/2014 |
Predviđena prijava poslana: | 08/26/2014 |
Prvo objavljeno: | 08/27/2014 |
Posljednje ažuriranje poslano: | 06/04/2018 |
Posljednje ažuriranje objavljeno: | 06/07/2018 |
Datum prvog podnošenja rezultata: | 12/12/2017 |
Datum prvog podnošenja rezultata QC: | 06/04/2018 |
Datum prvog objavljivanja rezultata: | 06/07/2018 |
Stvarni datum početka studija: | 07/31/2014 |
Procijenjeni datum primarnog završetka: | 08/31/2016 |
Procijenjeni datum završetka studije: | 08/31/2016 |
Stanje ili bolest
Intervencija / liječenje
Drug: IV Ibuprofen
Drug: IV Acetaminophen
Drug: Intravenous placebo/Intravenous placebo
Faza
Grupe ruku
Ruka | Intervencija / liječenje |
---|---|
Experimental: Intravenous Ibuprofen Ibuprofen 800mg IV piggyback and Saline IVP q 6 hours x 4 during uterine fibroid embolization | |
Experimental: Intravenous acetaminophen Acetaminophen 1 gram IV piggyback and Saline IVP q6 hours x 4 during uterine fibroid embolization | |
Experimental: IV ibuprofen/IV acetaminophen Ibuprofen 800 mg/ Acetaminophen 1 gram IV piggyback and Saline IVP 6 hours x 4 during uterine fibroid embolization | |
Active Comparator: Intravenous placebo/Intravenous placebo Saline/Saline IV piggyback and IVP Ketorolac 30 mg q6 hours x 4 during uterine fibroid embolization | Drug: Intravenous placebo/Intravenous placebo Uterine fibroid embolization |
Kriterij prihvatljivosti
Dobni uvjeti za studiranje | 21 Years Do 21 Years |
Spolovi koji ispunjavaju uvjete za studij | Female |
Prihvaća zdrave volontere | Da |
Kriteriji | Inclusion Criteria: 1. Patients being considered for UFE including bleeding and/or bulk symptoms. 2. Women of all ethnicities 3. Ages 21-60 Exclusion Criteria: 1. Patients with current malignancy receiving treatment 2. Women who are pregnant 3. Cognitive impairment 4. Clinically significant kidney disease 5. Clinically significant liver disease 6. Any recent history of gastrointestinal bleed or ulcer 7. Weight less than 50 kg (medication dosing requirements change below 50 kg) 8. Women with a body mass index (BMI) equal to or over 50 (with other co-morbidities) 9. Known allergy or hypersensitivity to NSAID or acetaminophen 10. Administration of acetaminophen, NSAID, narcotic or any other analgesic less than 6 hours prior to UFE procedure 11. Any chronic use of pain medications including acetaminophen, NSAID, narcotic or analgesic 12. Patients who cannot or choose not to consent to participate in the study |
Ishod
Primarne mjere ishoda
1. Evaluation of Maximum Pain Intensity Change Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen [24 hours]
2. Evaluation of Mean Pain Intensity Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen [24 hours]
Sekundarne mjere ishoda
1. Mean Nausea Intensity [24 hours]
2. Opioid Consumption [24 hours]
3. Anti-Emetic Consumption [24 hours]
4. Maximum Nausea Intensity [24 hours]