Intravenous Ibuprofen for Treatment of Post-Operative Pain: A Multicenter, Double Blind, Placebo-Controlled, Randomized Clinical Trial

Abstract

BackgroundNon-steroidal anti-inflammatory drugs are often used as components of multimodal therapy for postoperative pain management, but their use is currently limited by its side effects. The specific objective of this study was to evaluate the efficacy and safety of a new formulation of intravenous (IV) ibuprofen for the management of postoperative pain in a European population.Methods and FindingsA total of 206 patients from both abdominal and orthopedic surgery, were randomly assigned in 1:1 ratio to receive 800 mg IV-ibuprofen or placebo every 6 hours; all patients had morphine access through a patient controlled analgesia pump. The primary outcome measure was median morphine consumption within the first 24 hours following surgery. The mean±SEM of morphine requirements was reduced from 29,8±5,25 mg to 14,22±3,23 mg (p = 0,015) and resulted in a decrease in pain at rest (p = 0,02) measured by Visual Analog Scale (VAS) from mean±SEM 3.34±0,35 to 0.86±0.24, and also in pain during movement (p = 0,02) from 4.32±0,36 to 1.90±0,30 in the ibuprofen treatment arm; while in the placebo group VAS score at rest ranged from 4.68±0,40 to 2.12±0,42 and during movement from 5.66±0,42 to 3.38±0,44. Similar treatment-emergent adverse events occurred across both study groups and there was no difference in the overall incidence of these events.ConclusionsPerioperative administration of IV-Ibuprofen 800 mg every 6 hours in abdominal surgery patient’s decreases morphine requirements and pain score. Furthermore IV-Ibuprofen was safe and well tolerate. Consequently we consider appropriate that protocols for management of postoperative pain include IV-Ibuprofen 800 mg every 6 hours as an option to offer patients an analgesic benefit while reducing the potentially risks associated with morphine consumption.Trial RegistrationEU Clinical Trials Register 2011-005007-33

Comparison of Analgesic Effects of Paracetamol and Ibuprofen After Laparoscopic Cholecystectomy

“…21 A similar study conducted with the patients who had undergone abdominal surgery reported a decrease in morphine demand on day one, resting VAS score, and rescue analgesic requirement with 800 mg of IV ibuprofen administered at skin closure and at every 6 h postoperatively. 22 In our study, the VAS scores were significantly lower in Group IB than in Group P, particularly during the first 6 h. The total tramadol dose was lower in Group IB (136±83.61 mg) than in Group P (144 ± 93.91), although the difference was not significant (p>0.05). The number of the patients who required rescue analgesia in the PACU (p=0.01) and wards (p<0.05) were smaller in Group IB than in Group P. The PCA-delivered tramadol dose was similar despite different rescue analgesia requirement between the groups.…”

“…Intravenous ibuprofen is well-tolerated when used for treating pain and fever. [20][21][22] However, its most frequent side effects requiring immediate treatment are nausea, vomiting, headache, and urinary retention. Pruritus is the most important side effect that results in cessation of treatment and is observed in < 1% of patients.…”

Solubilization of ibuprofen for freeze dried parenteral dosage forms

“…Each vial with lyophilized powder contained 24 mg of IBP. In order to prepare the targeted IBP concentration for parenteral preparation, 4 mg mL -1 , 6 mL of WFI was added to the vial with the finished product (4). Afterwards, the vials were manually shaken and the time was measured until a clear solution, as determined by the naked eye, was obtained.…”

“…Considering the fact that solid pharmaceutical products represent almost 90 % of all pharmaceutical market, that 40 % of well-known drugs and 70 % of new drug candidates are poorly aqueous soluble, prediction of bioavailability and improvement of solubility is of crucial importance (1)(2)(3). Therefore, assurance of appropriate drug solubility is important and is a great challenge to scientists in formulating solid and liquid dosage forms to achieve sufficient solubility and physicochemical stability of poorly aqueous soluble drugs (4,5).…”

Acute pain intensity in men and women after septoplasty

“…Common methods of pain estimation are Visual Analogue Scale (VAS) [8,14,15], Numeric Rating Scale (NRS) [16][17][18], McGill pain index [19,20], etc. Likert scales are used for nasal symptoms (crusting, bleeding, sneezing, secretion, and nasal pain).…”