Ibuprofen IV vs Acetaminophen IV for the Treatment of Pain Following Orthopaedic Low Extremity Surgery
Primary Purpose
Lower Extremity Problem, Surgery, Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Ibuprofen
Acetaminophen
Sponsored by

About this trial
This is an interventional supportive care trial for Lower Extremity Problem focused on measuring ibuprofen, acetaminophen, orthopedic, VAS, morphine, opioid
Eligibility Criteria
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:
- 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
Sites / Locations
- Cipto Mangunkusumo Cental National Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ibuprofen group
Acetaminophen group
Arm Description
800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
Outcomes
Primary Outcome Measures
Pain intensity
demonstrated by the measurement VAS (Visual Analog Scale) for 24 hrs postoperative.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03771755
Brief Title
Ibuprofen IV vs Acetaminophen IV for the Treatment of Pain Following Orthopaedic Low Extremity Surgery
Official Title
A Prospective, Randomized, Double-blind Study Assessing the Efficacy of Intravenous (IV) Ibuprofen Versus IV Acetaminophen for the Treatment of Pain Following Orthopaedic Low Extremity Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to evaluate the efficacy of IV Ibuprofen versus IV Acetaminophen in the reduction of pain following orthopedic low extremity procedures
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Extremity Problem, Surgery, Postoperative Pain
Keywords
ibuprofen, acetaminophen, orthopedic, VAS, morphine, opioid
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibuprofen group
Arm Type
Active Comparator
Arm Description
800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
Arm Title
Acetaminophen group
Arm Type
Placebo Comparator
Arm Description
1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
Primary Outcome Measure Information:
Title
Pain intensity
Description
demonstrated by the measurement VAS (Visual Analog Scale) for 24 hrs postoperative.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
Facility Information:
Facility Name
Cipto Mangunkusumo Cental National Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19672167
Citation
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.
Results Reference
background
PubMed Identifier
11020770
Citation
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.
Results Reference
background
PubMed Identifier
11460814
Citation
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.
Results Reference
background
PubMed Identifier
18040817
Citation
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.
Results Reference
background
PubMed Identifier
12933409
Citation
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.
Results Reference
background
PubMed Identifier
11878721
Citation
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.
Results Reference
background
PubMed Identifier
21448308
Citation
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.
Results Reference
background
PubMed Identifier
12966473
Citation
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.
Results Reference
background
PubMed Identifier
10927999
Citation
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.
Results Reference
background
PubMed Identifier
19192939
Citation
Duggan ST, Scott LJ. Intravenous paracetamol (acetaminophen). Drugs. 2009;69(1):101-13. doi: 10.2165/00003495-200969010-00007.
Results Reference
background
PubMed Identifier
414527
Citation
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.
Results Reference
background
PubMed Identifier
1278245
Citation
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.
Results Reference
background
PubMed Identifier
10693878
Citation
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.
Results Reference
background
PubMed Identifier
2052056
Citation
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.
Results Reference
background
PubMed Identifier
14758785
Citation
Bonnefont J, Courade JP, Alloui A, Eschalier A. [Antinociceptive mechanism of action of paracetamol]. Drugs. 2003;63 Spec No 2:1-4. French.
Results Reference
background
PubMed Identifier
15662292
Citation
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.
Results Reference
background
PubMed Identifier
17270500
Citation
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.
Results Reference
background
PubMed Identifier
23459777
Citation
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.
Results Reference
background
PubMed Identifier
24267197
Citation
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.
Results Reference
background
PubMed Identifier
20591173
Citation
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.
Results Reference
background
PubMed Identifier
22621696
Citation
Scott LJ. Intravenous ibuprofen: in adults for pain and fever. Drugs. 2012 May 28;72(8):1099-109. doi: 10.2165/11209470-000000000-00000.
Results Reference
background
PubMed Identifier
19843482
Citation
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.
Results Reference
background
PubMed Identifier
20642488
Citation
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.
Results Reference
background
PubMed Identifier
20609131
Citation
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.
Results Reference
background
PubMed Identifier
26604816
Citation
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.
Results Reference
background
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Ibuprofen IV vs Acetaminophen IV for the Treatment of Pain Following Orthopaedic Low Extremity Surgery
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