Comparison of the Effectiveness of Preemptive Paracetamol and Ibuprofen in Acute Postoperative Pain

Sponsor

Ankara University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03063658

Collaborator

(none)

108

Enrollment

Locations

Arms

51.9

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate two different analgesic regimen used for acute postoperative pain.

Condition or Disease	Intervention/Treatment	Phase
Acute Pain Postoperative Pain	Drug: Paracetamol Drug: Ibuprofen 800 mg	Phase 4

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Comparison of the Postoperative Analgesia Effectiveness of Preemptive Intravenous Ibuprofen and Paracetamol in Patients Undergoing Laparoscopic Cholecystectomy

Actual Study Start Date :

Feb 1, 2017

Anticipated Primary Completion Date :

Oct 31, 2020

Anticipated Study Completion Date :

May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: 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.
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.

Arm

Intervention/Treatment

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.

Drug: 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.

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.

Outcome Measures

Primary Outcome Measures

Morphine consumption [The first 24 hours after the completion of the surgery]
Total morphine consumption during the 24 hours of early postoperative period

Secondary Outcome Measures

VAS scores [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 [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