PMID- 36926379 OWN - NLM STAT- MEDLINE DCOM- 20230320 LR - 20230425 IS - 1918-1523 (Electronic) IS - 1203-6765 (Print) IS - 1203-6765 (Linking) VI - 2023 DP - 2023 TI - Analgesic Efficacy of Intravenous Ibuprofen in the Treatment of Postoperative Acute Pain: A Phase III Multicenter Randomized Placebo-ControlledDouble-Blind Clinical Trial. PG - 7768704 LID - 10.1155/2023/7768704 [doi] LID - 7768704 AB - OBJECTIVE: To evaluate the analgesic efficacy and safety of different does of intravenous ibuprofen (IVIB) in the treatment of postoperative acute pain. METHODS: Patients with an intravenous (IV) patient-controlled analgesia device after abdominal or orthopedic surgery were randomly divided into placebo, IVIB 400 mg, and IVIB 800 mg groups. The first dosage of study medicines was given intravenously 30 minutes (min) before surgery ended, followed by six hours (h) intervals for a total of eight doses following surgery. The demographic characteristics and procedure data, cumulative morphine consumption, the visual analog scale (VAS), the area under the curve (AUC) of VAS, patient satisfaction score (PSS), the rates of treatment failure (RTF), and adverse events (AEs) and serious adverse event (SAEs) were recorded during the period of trial. RESULT: A total of 345 patients were enrolled in the full analysis set (FAS), and of 326 participants were valid data set (VDS). Demographic characteristics, disease features, and medical history of patients were not significantly different between groups. Total morphine consumption of the IVIB 400 mg group (11.14 +/- 7.14 mg; P = 0.0011) and the IVIB 800 mg group (11.29 +/- 6.45 mg; P = 0.0014) was significantly reduced compared with the placebo group (14.51 +/- 9.19 mg) for 24 h postoperatively, there was no significant difference between the IVIB 400 mg and IVIB 800 mg groups (P = 0.9997). The placebo group had significantly higher VAS and the AUCs of VAS than those in the IVIB 400 mg and the IVIB 800 mg groups at rest and movement for 24 h postoperatively (P < 0.05), and there was no significant difference between the IVIB 400 mg and IVIB 800 mg groups (P > 0.05). RTF was slightly higher in the placebo group than IVIB 400 mg group and 800 mg group, and no statistical significance (P < 0.690). PSS in the IVIB 400 mg (P = 0.0092) and the IVIB 800 mg groups (P = 0.0011) was higher than the placebo group for pain management, there was also no significant difference between the IVIB 400 mg and IVIB 800 mg groups (P = 0.456). The incidence of RTF (P = 0.690) and AEs (P > 0.05) were not different among the three groups. CONCLUSION: Intermittent IV administration of ibuprofen 400 mg or 800 mg within 24 h after surgery in patients undergoing abdominal and orthopedic surgery significantly decreased morphine consumption and relieved pain, without increasing the incidence of AEs. CI - Copyright (c) 2023 Hong-Su Zhou et al. FAU - Zhou, Hong-Su AU - Zhou HS AUID- ORCID: 0000-0003-3337-8168 AD - Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou 563000, China. FAU - Li, Ting-Ting AU - Li TT AUID- ORCID: 0000-0001-6041-6719 AD - Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610044, China. FAU - Pi, Yu AU - Pi Y AUID- ORCID: 0000-0002-2499-7605 AD - Department of Anesthesiology, South West Medical University, Luzhou 646000, China. FAU - Wang, Ting-Hua AU - Wang TH AUID- ORCID: 0000-0003-2012-8936 AD - Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou 563000, China. AD - Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610044, China. FAU - Liu, Fei AU - Liu F AUID- ORCID: 0000-0002-9970-1338 AD - Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610044, China. FAU - Xiong, Liu-Lin AU - Xiong LL AUID- ORCID: 0000-0002-1623-5969 AD - Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou 563000, China. LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20230307 PL - United States TA - Pain Res Manag JT - Pain research & management JID - 9612504 RN - WK2XYI10QM (Ibuprofen) RN - 0 (Analgesics, Opioid) RN - 0 (Analgesics) RN - 76I7G6D29C (Morphine) SB - IM MH - Humans MH - *Ibuprofen/therapeutic use MH - *Acute Pain/drug therapy/etiology MH - Analgesics, Opioid/therapeutic use MH - Analgesics/therapeutic use MH - Pain, Postoperative/drug therapy/etiology MH - Morphine/therapeutic use MH - Double-Blind Method PMC - PMC10014159 COIS- The authors declare that they have no conflicts of interest. EDAT- 2023/03/18 06:00 MHDA- 2023/03/21 06:00 PMCR- 2023/03/07 CRDT- 2023/03/17 02:49 PHST- 2022/09/14 00:00 [received] PHST- 2023/01/05 00:00 [revised] PHST- 2023/02/07 00:00 [accepted] PHST- 2023/03/17 02:49 [entrez] PHST- 2023/03/18 06:00 [pubmed] PHST- 2023/03/21 06:00 [medline] PHST- 2023/03/07 00:00 [pmc-release] AID - 10.1155/2023/7768704 [doi] PST - epublish SO - Pain Res Manag. 2023 Mar 7;2023:7768704. doi: 10.1155/2023/7768704. eCollection 2023.