search
Back to results

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

Primary Purpose

Acute Pain, Postoperative Pain

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Paracetamol
Ibuprofen 800 mg
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Pain focused on measuring Ibuprofen, Paracetamol, Laparoscopic cholecystectomy, Morphine, Visual analog scale

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. American Society of Anesthesiologist Functional Status 1-2
  2. Body mass index smaller than 30
  3. Undergoing laparoscopic cholecystectomy
  4. Age between 18-60 years

Exclusion Criteria:

  1. Age under 18, above 60
  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

Sites / Locations

  • Ankara University Faculty of Medicine
  • Ankara University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Paracetamol

Ibuprofen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Morphine consumption
Total morphine consumption during the 24 hours of early postoperative period

Secondary Outcome Measures

VAS scores
VAS scores at rest, at movement, at cough will be evaluated during the first 24 hours of early postoperative period
Morphine side effects
Morphine side effects such as nausea, vomiting, pruritus, constipation, urinary retention will be evaluated during the first 24 hours of early postoperative period

Full Information

First Posted
February 21, 2017
Last Updated
July 4, 2019
Sponsor
Ankara University
search

1. Study Identification

Unique Protocol Identification Number
NCT03063658
Brief Title
Comparison of the Effectiveness of Preemptive Paracetamol and Ibuprofen in Acute Postoperative Pain
Official Title
Comparison of the Postoperative Analgesia Effectiveness of Preemptive Intravenous Ibuprofen and Paracetamol in Patients Undergoing Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
May 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Postoperative Pain
Keywords
Ibuprofen, Paracetamol, Laparoscopic cholecystectomy, Morphine, Visual analog scale

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paracetamol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 800 mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Morphine consumption
Description
Total morphine consumption during the 24 hours of early postoperative period
Time Frame
The first 24 hours after the completion of the surgery
Secondary Outcome Measure Information:
Title
VAS scores
Description
VAS scores at rest, at movement, at cough will be evaluated during the first 24 hours of early postoperative period
Time Frame
The first 24 hours after the completion of the surgery
Title
Morphine side effects
Description
Morphine side effects such as nausea, vomiting, pruritus, constipation, urinary retention will be evaluated during the first 24 hours of early postoperative period
Time Frame
The first 24 hours after the completion of the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologist Functional Status 1-2 Body mass index smaller than 30 Undergoing laparoscopic cholecystectomy Age between 18-60 years Exclusion Criteria: Age under 18, above 60 Weight under 40 kg Body mass index above 30 Contraindication for opioid and non-steroid anti-inflammatory drug usage Allergy against paracetamol, opioids and anti-inflammatory drugs Peptic ulcer Tendency to bleeding Pregnancy or breast feeding Moderate or severe renal, hepatic or cardiac insufficiency Coronary artery disease Asthma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Menekse Ozcelik, M.D
Phone
+905333521400
Email
ozcelikmenekse@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zekeriyya Alanoglu, Professor
Organizational Affiliation
Ankara University Department of Anesthesiology and Intensive Care Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara University Faculty of Medicine
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Ankara University School of Medicine
City
Ankara
ZIP/Postal Code
06660
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neslihan Alkis, Prof
Phone
+905323435055
Email
alkisneslihan@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
27152748
Citation
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.
Results Reference
background
PubMed Identifier
25592331
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs