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CompletedNCT03771755Updated Aug 20, 2020

Ibuprofen IV vs Acetaminophen IV for the Treatment of Pain Following Orthopaedic Low Extremity Surgery

An interventional study of Ibuprofen and Acetaminophen in Lower Extremity Problem, Surgery and Postoperative Pain, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-08-20.

Sponsored by Indonesia University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Jul 2017, registered Dec 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study aims to evaluate the efficacy of IV Ibuprofen versus IV Acetaminophen in the reduction of pain following orthopedic low extremity procedures

Read the detailed description

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Patients undergoing orthopedic low extremity surgery were screened. Eligible subjects were then randomized into treatment group (intravenous ibuprofen) and control group (intravenous acetaminophen). In case required, patients from both group will be given Morphine (PCA) 1-2 mg every 5 minutes.

02

Conditions studied

  • Lower Extremity Problem
  • Surgery
  • Postoperative Pain

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Keywords

  • ibuprofen
  • acetaminophen
  • orthopedic
  • VAS
  • morphine
  • opioid
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 62 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Scheduled for Orthopedic Low Extremity Surgery with general anesthesia and anticipated need post operative IV analgesia with anticipated use of >48 hours.
  • Adequate IV access.
  • Anticipated hospital stay>48 hours.
  • Age 18-70 years old with physical status ASA I- III.
  • Patients able to fill informed consent sheet.

Exclusion criteria

Exclusion Criteria:

  • patients with use of analgesia, muscle relaxants, NSAIDs and sedatives less than 24 hours to study drug administration
  • anemia (active, clinically significant anemia) and/or a history or evidence of asthma or heart failure
  • historical or at higher risk intracerebral bleeding, history of allergy or hypersensitive to NSAID, Ibuprofen, Acetaminophen or opioid
  • pregnant or nursing
  • body weight less than 30 kg
  • any active clinically significant bleeding or have underlying platelet dysfunction and/or receiving full dose anticoagulation therapy
  • GI bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
  • on dialysis or renal dysfunction
  • impaired liver function
  • inability to achieve hemostasis or inability to close surgical incision prior to operating room discharge
  • operative procedure includes organ transplant, pre-and intra- operative procedure utilized for the prevention of pre- or post-operative pain (i.e, epidural or nerve blocks)
  • received anoher investigational drug within the past 30 days
  • known or suspected history of alcohol or drug abuse
  • severe infection and/or inflammatory disease
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
62 participants (actual)

Study arms

  • Active comparator
    Ibuprofen group

    800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes

    Drug: Ibuprofen

  • Placebo comparator
    Acetaminophen group

    1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes

    Drug: Acetaminophen

Interventions

  • DrugIbuprofen

    800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes

  • DrugAcetaminophen

    1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes

06

What researchers measure

Primary outcomes

  1. Pain intensity

    demonstrated by the measurement VAS (Visual Analog Scale) for 24 hrs postoperative.

    Time frame: 24 hours

07

Study locations

1 site
  • Cipto Mangunkusumo Cental National Hospital
    Jakarta, DKI Jakarta 10430, Indonesia
08

References and documents

Publications

  • Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a. PubMed 19672167 ↗
  • Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available. PubMed 11020770 ↗
  • Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available. PubMed 11460814 ↗
  • Shavit Y, Fridel K, Beilin B. Postoperative pain management and proinflammatory cytokines: animal and human studies. J Neuroimmune Pharmacol. 2006 Dec;1(4):443-51. doi: 10.1007/s11481-006-9043-1. Epub 2006 Sep 29. PubMed 18040817 ↗
  • Beilin B, Shavit Y, Trabekin E, Mordashev B, Mayburd E, Zeidel A, Bessler H. The effects of postoperative pain management on immune response to surgery. Anesth Analg. 2003 Sep;97(3):822-827. doi: 10.1213/01.ANE.0000078586.82810.3B. PubMed 12933409 ↗
  • Hall GM, Peerbhoy D, Shenkin A, Parker CJ, Salmon P. Relationship of the functional recovery after hip arthroplasty to the neuroendocrine and inflammatory responses. Br J Anaesth. 2001 Oct;87(4):537-42. doi: 10.1093/bja/87.4.537. PubMed 11878721 ↗
  • Esme H, Kesli R, Apiliogullari B, Duran FM, Yoldas B. Effects of flurbiprofen on CRP, TNF-alpha, IL-6, and postoperative pain of thoracotomy. Int J Med Sci. 2011 Mar 10;8(3):216-21. doi: 10.7150/ijms.8.216. PubMed 21448308 ↗
  • Dionne RA, Gordon SM, Rowan J, Kent A, Brahim JS. Dexamethasone suppresses peripheral prostanoid levels without analgesia in a clinical model of acute inflammation. J Oral Maxillofac Surg. 2003 Sep;61(9):997-1003. doi: 10.1016/s0278-2391(03)00310-0. PubMed 12966473 ↗
  • Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available. PubMed 10927999 ↗
  • Duggan ST, Scott LJ. Intravenous paracetamol (acetaminophen). Drugs. 2009;69(1):101-13. doi: 10.2165/00003495-200969010-00007. PubMed 19192939 ↗
  • Glenn EM, Bowman BJ, Rohloff NA. Anti-inflammatory and PG inhibitory effects of phenacetin and acetaminophen. Agents Actions. 1977 Dec;7(5-6):513-6. doi: 10.1007/BF02111123. PubMed 414527 ↗
  • Vinegar R, Truax JF, Selph JL. Quantitative comparison of the analgesic and anti-inflammatory activities of aspirin, phenacetin and acetaminophen in rodents. Eur J Pharmacol. 1976 May;37(1):23-30. doi: 10.1016/0014-2999(76)90004-2. PubMed 1278245 ↗
  • Wolfe F, Zhao S, Lane N. Preference for nonsteroidal antiinflammatory drugs over acetaminophen by rheumatic disease patients: a survey of 1,799 patients with osteoarthritis, rheumatoid arthritis, and fibromyalgia. Arthritis Rheum. 2000 Feb;43(2):378-85. doi: 10.1002/1529-0131(200002)43:23.0.CO;2-2. PubMed 10693878 ↗
  • Bradley JD, Brandt KD, Katz BP, Kalasinski LA, Ryan SI. Comparison of an antiinflammatory dose of ibuprofen, an analgesic dose of ibuprofen, and acetaminophen in the treatment of patients with osteoarthritis of the knee. N Engl J Med. 1991 Jul 11;325(2):87-91. doi: 10.1056/NEJM199107113250203. PubMed 2052056 ↗
  • Bonnefont J, Courade JP, Alloui A, Eschalier A. [Antinociceptive mechanism of action of paracetamol]. Drugs. 2003;63 Spec No 2:1-4. French. PubMed 14758785 ↗
  • Graham GG, Scott KF. Mechanism of action of paracetamol. Am J Ther. 2005 Jan-Feb;12(1):46-55. doi: 10.1097/00045391-200501000-00008. PubMed 15662292 ↗
  • Khan AA, Iadarola M, Yang HY, Dionne RA. Expression of COX-1 and COX-2 in a clinical model of acute inflammation. J Pain. 2007 Apr;8(4):349-54. doi: 10.1016/j.jpain.2006.10.004. Epub 2007 Jan 30. PubMed 17270500 ↗
  • Kashefi P, Honarmand A, Safavi M. Effects of preemptive analgesia with celecoxib or acetaminophen on postoperative pain relief following lower extremity orthopedic surgery. Adv Biomed Res. 2012;1:66. doi: 10.4103/2277-9175.100197. Epub 2012 Aug 28. PubMed 23459777 ↗
  • Crofford LJ. Use of NSAIDs in treating patients with arthritis. Arthritis Res Ther. 2013;15 Suppl 3(Suppl 3):S2. doi: 10.1186/ar4174. Epub 2013 Jul 24. PubMed 24267197 ↗
  • Morris PE, Promes JT, Guntupalli KK, Wright PE, Arons MM. A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults. Crit Care. 2010;14(3):R125. doi: 10.1186/cc9089. Epub 2010 Jun 30. PubMed 20591173 ↗
  • Scott LJ. Intravenous ibuprofen: in adults for pain and fever. Drugs. 2012 May 28;72(8):1099-109. doi: 10.2165/11209470-000000000-00000. PubMed 22621696 ↗
  • Southworth S, Peters J, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative pain. Clin Ther. 2009 Sep;31(9):1922-35. doi: 10.1016/j.clinthera.2009.08.026. PubMed 19843482 ↗
  • Kroll PB, Meadows L, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen (i.v.-ibuprofen) in the management of postoperative pain following abdominal hysterectomy. Pain Pract. 2011 Jan-Feb;11(1):23-32. doi: 10.1111/j.1533-2500.2010.00402.x. PubMed 20642488 ↗
  • Singla N, Rock A, Pavliv L. A multi-center, randomized, double-blind placebo-controlled trial of intravenous-ibuprofen (IV-ibuprofen) for treatment of pain in post-operative orthopedic adult patients. Pain Med. 2010 Aug;11(8):1284-93. doi: 10.1111/j.1526-4637.2010.00896.x. Epub 2010 Jun 30. PubMed 20609131 ↗
  • Southworth SR, Woodward EJ, Peng A, Rock AD. An integrated safety analysis of intravenous ibuprofen (Caldolor((R))) in adults. J Pain Res. 2015 Oct 23;8:753-65. doi: 10.2147/JPR.S93547. eCollection 2015. PubMed 26604816 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03771755
Lead sponsor
Indonesia University
Responsible party
Aida Rosita Tantri (Principal Investigator, Indonesia University) — Principal investigator
First posted
Dec 11, 2018
Start date
Jul 1, 2017
Primary completion
Nov 30, 2017
Completion
Nov 30, 2017
Last update
Aug 20, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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