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Trial record 2 of 815 for:    IBUPROFEN

Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Morphine Consumption in Lumbar Disc Surgery (ibuprofen)

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ClinicalTrials.gov Identifier: NCT03437707
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Sedat AKBAS, Inonu University

Brief Summary:
Primary aim of this prospective, randomized, double-blind, placebo-controlled clinical trial is to compare the analgesic effects of IV ibuprofen and paracetamol on postoperative pain, and secondary aim is the effects on morphine consumption and side effects of morphine in patients who underwent lumbar disc surgery with a single level laminectomy or discectomy.

Condition or disease Intervention/treatment Phase
Postoperative Pain Management Drug: Morphine Sulfate Drug: Intravenous paracetamol Drug: Intravenous ibuprofen Not Applicable

Detailed Description:

All surgical procedures are associated with acute pain and inflammation, with varying degrees of severity for patients, causing significant stress and discomfort. Effective postoperative pain management in lumbar disc surgery may reduce complications and improve postoperative care. For postoperative pain, multimodal analgesic techniques are used to provide synergistic effects through different nociceptive mechanisms.

Various analgesics are used for pain. Opioids, commonly used for postoperative pain, are the most popular drug group. Side effects such as sedation, respiratory depression, nausea-vomiting, pruritus and urinary retention that develop secondary to opioids may also be reduced by the combination of supplemental analgesics.

Adjuvant agents, including nonsteroidal anti-inflammatory drugs (NSAID), may be used in combination with opioids. These drugs not only reduce pain but also control the underlying inflammatory process. In addition, combining NSAIDs and opioids can help to reduce the side effects by minimizing administration of total opioid consumption.

Intravenous (IV) ibuprofen is the first and only IV NSAID approved in the United States for both pain and fever control in adults. It has been reported in multicenter studies that IV ibuprofen is safe and effective in postoperative pain management for abdominal hysterectomy and orthopedic surgeries.

IV paracetamol is an analgesic and antipyretic agent used as a first step drug for pain and fever control in adults and children. It has been clearly shown that IV paracetamol, with analgesic efficacy and good safety profile, reduces analgesic requirements for pain management. It provides better analgesic efficacy and reduces opioid consumption when used in combination with opioids.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Randomized, Placebo-Controlled Clinical Trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Morphine Consumption in Lumbar Disc Surgery: Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Actual Study Start Date : February 13, 2018
Actual Primary Completion Date : August 6, 2018
Actual Study Completion Date : August 13, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo
250 ml saline will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Drug: Morphine Sulfate
Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Other Name: Intravenous patient-controlled analgesia

Active Comparator: Intravenous paracetamol
1 g paracetamol will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Drug: Morphine Sulfate
Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Other Name: Intravenous patient-controlled analgesia

Drug: Intravenous paracetamol
1 g paracetamol will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Other Name: paracetamol

Active Comparator: Intravenous ibuprofen
800 mg ibuprofen (diluted with 250 ml saline) will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Drug: Morphine Sulfate
Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Other Name: Intravenous patient-controlled analgesia

Drug: Intravenous ibuprofen
800 mg ibuprofen (diluted with 250 ml saline) will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
Other Name: ibuprofen




Primary Outcome Measures :
  1. Postoperative pain scores [ Time Frame: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours ]
    Visual Analog Scale (VAS, 0-10)


Secondary Outcome Measures :
  1. Sedation score [ Time Frame: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours ]
    Ramsey sedation score (1-6)

  2. Morphine consumption [ Time Frame: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours ]
    Morphine



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists scores 1-3
  • 18-85 years

Exclusion Criteria:

  • American Society of Anesthesiologists scores IV,
  • Under the age of 18,
  • Over the age of 85,
  • Peptic ulcer disease,
  • Hepatic and renal dysfunction,
  • Severe cardiovascular and pulmonary disease,
  • Allergic history to propofol, fentanyl, rocuronium, paracetamol, ibuprofen and morphine,
  • Emergency surgery,
  • Refused informed consent form

Information from the National Library of Medicine

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): NCT03437707


Locations
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Turkey
Sedat AKBAS
Malatya, Türkiye-Türkçe, Turkey, 44090
Sponsors and Collaborators
Inonu University
Investigators
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Study Director: Sedat AKBAS Inonu University Medical Faculty
  Study Documents (Full-Text)

Documents provided by Sedat AKBAS, Inonu University:

Publications of Results:
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Responsible Party: Sedat AKBAS, Asst. Prof., Inonu University
ClinicalTrials.gov Identifier: NCT03437707     History of Changes
Other Study ID Numbers: sedatakbas2
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Sedat AKBAS, Inonu University:
Postoperative pain
Intravenous ibuprofen
Intravenous paracetamol
Lumbar disc surgery
Additional relevant MeSH terms:
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Ibuprofen
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Morphine
Pharmaceutical Solutions
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics