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

NCT03063658 | Unknown Phase 4

• 1 other identifier: 16-827-16
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Acute Pain; Postoperative Pain

Keywords

Ibuprofen; Paracetamol; Laparoscopic cholecystectomy; Morphine; Visual analog scale

Outcome Measures

Primary Outcomes (1)

• Morphine consumption

  Total morphine consumption during the 24 hours of early postoperative period

  The first 24 hours after the completion of the surgery

Secondary Outcomes (2)

• VAS scores

  The first 24 hours after the completion of the surgery

• Morphine side effects

  The first 24 hours after the completion of the surgery

Study Arms (2)

Paracetamol

ACTIVE COMPARATOR

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

Ibuprofen

ACTIVE COMPARATOR

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

Interventions

Paracetamol DRUG

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.

Paracetamol

Ibuprofen 800 mg DRUG

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.

Ibuprofen

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (2)

Ankara University Faculty of Medicine

Ankara, 06100, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Ankara University School of Medicine

Ankara, 06660, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 20609131 BACKGROUND

• 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.

  PMID: 27152748 BACKGROUND

• 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.

  PMID: 25592331 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Zekeriyya Alanoglu, Professor

  Ankara University Department of Anesthesiology and Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Menekse Ozcelik, M.D

CONTACT

+905333521400; ozcelikmenekse@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Study Start: February 1, 2017
• Primary Completion: October 31, 2020
• Study Completion: May 31, 2021
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)