Comparison of the Effectiveness of Preemptive Paracetamol and Ibuprofen in Acute Postoperative Pain
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|ClinicalTrials.gov Identifier: NCT03063658|
Recruitment Status : Recruiting
First Posted : February 24, 2017
Last Update Posted : July 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain Postoperative Pain||Drug: Paracetamol Drug: Ibuprofen 800 mg||Phase 4|
Laparoscopic cholecystectomy is a type of surgery that causes moderate postoperative pain. Paracetamol and non-steroid anti-inflammatory analgesics plus opioids are the mainstay treatment options of the moderate postoperative pain. These drugs are the most common used analgesics to ameliorate this type of pain and to reduce the consumption of opioids and their side effects.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparison of the Postoperative Analgesia Effectiveness of Preemptive Intravenous Ibuprofen and Paracetamol in Patients Undergoing Laparoscopic Cholecystectomy|
|Actual Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||May 31, 2021|
Active Comparator: 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.
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.
Active Comparator: 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.
Drug: 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.
- Morphine consumption [ Time Frame: The first 24 hours after the completion of the surgery ]Total morphine consumption during the 24 hours of early postoperative period
- VAS scores [ Time Frame: The first 24 hours after the completion of the surgery ]VAS scores at rest, at movement, at cough will be evaluated during the first 24 hours of early postoperative period
- Morphine side effects [ Time Frame: The first 24 hours after the completion of the surgery ]Morphine side effects such as nausea, vomiting, pruritus, constipation, urinary retention will be evaluated during the first 24 hours of early postoperative period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063658
|Contact: Menekse Ozcelik, M.Demail@example.com|
|Ankara University Faculty of Medicine||Active, not recruiting|
|Ankara, Turkey, 06100|
|Ankara University School of Medicine||Recruiting|
|Ankara, Turkey, 06660|
|Contact: Neslihan Alkis, Prof +905323435055 firstname.lastname@example.org|
|Principal Investigator:||Zekeriyya Alanoglu, Professor||Ankara University Department of Anesthesiology and Intensive Care Medicine|