Comparison of the Effectiveness of Preemptive Paracetamol and Ibuprofen in Acute Postoperative Pain
NCT ID: NCT03063658
Last Updated: 2019-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
108 participants
INTERVENTIONAL
2017-02-01
2021-05-31
Brief Summary
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Detailed Description
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Ibuprofen is a well-known anti-inflammatory drug and has been used as an oral formula for a long time. Few studies using its new intravenous formula had been conducted to evaluate its effectiveness for mixed type of surgeries . However, its intravenous formula has not been studied for laparoscopic cholecystectomy. Therefore, this study will compare the effects of postoperative analgesic potencies of preemptive intravenous paracetamol and ibuprofen in patients undergoing laparoscopic cholecystectomy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Paracetamol
Paracetamol (Paracerol) 1 gram will be administered intravenously. The first dose will be infused for 10 minutes after the induction of anesthesia and before the first surgical incision. The remaining three doses will be administered every 6 hours for postoperative 24 hours.
Paracetamol
The first dose of 1 gr intravenous paracetamol will be administered preoperatively and the remaining three doses will be given each six hours in the early postoperative period.
Ibuprofen
Ibuprofen (Intrafen) 800 mg will be administered intravenously. The first dose will be infused for 10 minutes after the induction of anesthesia and before the first surgical incision. The remaining three doses will be administered every 6 hours for postoperative 24 hours.
Ibuprofen 800 mg
The first dose of 800 mg intravenous ibuprofen will be administered preoperatively and the remaining three doses will be given each six hours in the early postoperative period.
Interventions
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Paracetamol
The first dose of 1 gr intravenous paracetamol will be administered preoperatively and the remaining three doses will be given each six hours in the early postoperative period.
Ibuprofen 800 mg
The first dose of 800 mg intravenous ibuprofen will be administered preoperatively and the remaining three doses will be given each six hours in the early postoperative period.
Eligibility Criteria
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Inclusion Criteria
2. Body mass index smaller than 30
3. Undergoing laparoscopic cholecystectomy
4. Age between 18-60 years
Exclusion Criteria
2. Weight under 40 kg
3. Body mass index above 30
4. Contraindication for opioid and non-steroid anti-inflammatory drug usage
5. Allergy against paracetamol, opioids and anti-inflammatory drugs
6. Peptic ulcer
7. Tendency to bleeding
8. Pregnancy or breast feeding
9. Moderate or severe renal, hepatic or cardiac insufficiency
10. Coronary artery disease
11. Asthma
18 Years
60 Years
ALL
No
Sponsors
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Ankara University
OTHER
Responsible Party
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Menekse Ozcelik
M.D
Principal Investigators
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Zekeriyya Alanoglu, Professor
Role: PRINCIPAL_INVESTIGATOR
Ankara University Department of Anesthesiology and Intensive Care Medicine
Locations
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Ankara University Faculty of Medicine
Ankara, , Turkey (Türkiye)
Ankara University School of Medicine
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Gago Martinez A, Escontrela Rodriguez B, Planas Roca A, Martinez Ruiz A. Intravenous Ibuprofen for Treatment of Post-Operative Pain: A Multicenter, Double Blind, Placebo-Controlled, Randomized Clinical Trial. PLoS One. 2016 May 6;11(5):e0154004. doi: 10.1371/journal.pone.0154004. eCollection 2016.
Gan TJ, Candiotti K, Turan A, Buvanendran A, Philip BK, Viscusi ER, Soghomonyan S, Bergese SD; Intravenous Ibuprofen Surgical Surveillance Trial Investigational Sites. The shortened infusion time of intravenous ibuprofen, part 2: a multicenter, open-label, surgical surveillance trial to evaluate safety. Clin Ther. 2015 Feb 1;37(2):368-75. doi: 10.1016/j.clinthera.2014.12.006. Epub 2015 Jan 13.
Other Identifiers
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16-827-16
Identifier Type: -
Identifier Source: org_study_id
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