Table 1.
Eligibility criteria for participants.
Fig 1.
Distribution of patients randomized to receive IV-Ibuprofen or placebo for the management of postoperative pain.
ICF: Informed Consent Form. a Safety: all patients who received at least one dose of IV-Ibuprofen or placebo (patients from both type of surgery abdominal and orthopedic) b Efficacy: all patients from abdominal surgery who received at least 4 doses of IV ibuprofen or placebo within 30 minutes of the scheduled administration time. Reasons for exclusion from the efficacy population included adverse events, noncompliance, and lack of efficacy, among others that resulted in the failure to complete the study protocol. Excluded from Efficacy analysis all patients from Orthopaedic surgery (because of the low rate of enrolment of patients due to the type of anaesthetic technique used mostly regional type): Ibuprofen arm: ITT n = 15; PP n = 14. Placebo group: ITT n = 16; PP n = 14. c ITT = Intention to Treat: population consisted of all patients who were both randomized and treated. d PP = Per Protocol: population consisted of all patients from the ITT population who had received the study treatment for at least 24 hours.
Fig 2.
a Site closure. b IV-Ibuprofen 800 mg or saline placebo, up to 24 hours for abdominal surgery and up to 72 hours for orthopedic surgery. c Counted since the last dose administered.
Table 2.
Summary of Baseline Demographics and Patient Characteristics.
Table 3.
Data related to Morphine consumption during the first 24 hours post-surgery.
Fig 3.
Evolution of postoperative pain at rest.
Patients self-reported pain scores during the immediate 24 hours after surgery were plotted for the IV-ibuprofen and placebo treatment groups. Values are mean±SEM. *Treatment doses: First intra-operative administration (T = 0), followed by doses 2, 3, 4 and 5 administered at hours 6, 12, 18 and 24 after surgery.
Fig 4.
Evolution of postoperative pain during movement.
Patients self-reported pain scores during the immediate 24 hours after surgery were plotted for the IV-ibuprofen and placebo treatment groups. Values are mean±SEM. *Treatment doses: First intra-operative administration (T = 0), followed by doses 2, 3, 4 and 5 administered at hours 6, 12, 18 and 24 after surgery.
Table 4.
Adverse events summary.