Comparison of Intravenous Ibuprofen and Ketorolac for Acute Musculoskeletal Pain from Various Etiologies
Tahapan Penelitian : Initial
Sponsor:
Duta Wacana Christian University School of Medicine, Yogyakarta, Indonesia
Mitra Pelaksana:
Bethesda Hospital, Yogyakarta, Indonesia
No Registry
INA-F3KQ3DK
Tanggal Input Registry : 01-12-2019
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 09-12-2019 |
| Outcome Primer | Visual Analogue Scale (vas) for pain intensity that measured in 1 hour and every 8 hours after the medication administration for total 48 hours after admission. |
| Outcome Skunder | 1. Physician global assessments 2. Patients global assessments 3. Total rescue medication after 48 hours of the medication administration using VAS 4. Safety profile of the medication 5. Consumption of rescue pain medication in 48 hours after the initiation of medication administration. |
| Descriptive Information | |
| Judul Penelitian Popular | Comparison of Intravenous Ibuprofen and Ketorolac for Acute Musculoskeletal Pain from Various Etiologies |
| Judul Penelitian Ilmiah | Comparison of Intravenous Ibuprofen and Ketorolac for Acute Musculoskeletal Pain from Various Etiologies |
| Jenis Penelitian | Interventional |
| Intervensi | This is a quasi experimental, non randomized, non equivalent, active comparator, open label study. The intervention in this study is an intravenous 800 mg ibuprofen. The intravenous ibuprofen will be given every 12 hours. We will need 4 intravenous ibuprofen injection for every patient. There will be a total need of 120 IV ibuprofen injection for this study. The control in this study is an intravenous 30 mg ketorolac. The ketorolac injection will be given every 12 hours. |
| Jumlah Subyek Penelitian | 60 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Inclusion criteria : 1. Male and female 2. > 18 years old 3. Acute moderate to severe (VAS > 4) musculoskeletal pain from various etiologies. 4. In-patients at Bethesda Hospital, Yogyakarta, Indonesia. 5. No consumption of any Non-steroid Antiinflammatory Drug (NSAID) 3 hours before the study. 6. Alert, cooperative, able to communicate their pain.Exclusion Criteria: Exclusion criteria : 1. Subjects with significant renal and liver problem. 2. Subjects with known hypersensitivity with either ibuprofen or ketorolac. 3. Pregnancy and breastfeeding patients. 4. Patients that enrolled any clinical trial within a month. 5. Unwillingness to join the study. |
| Administrative Information | |
| Nomor Persetujuan Etik | 1094/C.16/FK/2019 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | 02/PZ/XII/2019 |
| Contact Person | dr. Rosa De Lima Renita Sanyasi |