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Ketamine Versus Morphine Change Pain Profile

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ClinicalTrials.gov Identifier: NCT03664622
Recruitment Status : Not yet recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Hassan Mohamed Ali, Cairo University

Brief Summary:
The aim of this study is to evaluate the efficacy of intravenous low dose ketamine infusion versus morphine infusion analgesia for pain reduction in Abdominoplasty surgery

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Ketamine Drug: Morphine Not Applicable

Detailed Description:
Abdominoplasty is considered one of the most commonly performed cosmetic procedures. According to statistics from the International Society of Aesthetic Plastic Surgery, a total of 758,590 abdominoplasties were performed in the world in 2016. This is an increase of 72.95% in comparison with 2011, making it the fourth most common cosmetic procedure. Given the increasing number of abdominoplasties performed, the importance of understanding the possible complications and morbidity associated with the procedure is critical. One of these complications is the postoperative pain. With adequate postoperative pain control, the patients met discharge criteria sooner and this helps in shortening the hospital stay, better overall patient satisfaction, and decreased hospital costs. Therefore, the severity of this problem and the all drug agent used to prevent and treat postoperative pain best interest to be aware in the anesthesiologists. Traditionally, analgesia for abdominal wall surgery is provided either by systemic drugs such as opioids, nonsteroidal anti-inflammatories, alpha 2 agonists and paracetamol or by epidural analgesia. However, Opioids, such as morphine or fentanyl, remain the mainstay of postoperative analgesic regimens for patients after abdominal wall surgery. The pain is not always fully relieved by such agents, and often patients develop tolerance to them. The ever-increasing doses of opioids are clearly not without their adverse effects. (5) For this Alternative approaches, which reduce the requirement for strong opioids post-operative, are required. Recently, interest has focused on the use of N-methyl-D-aspartate (NMDA) receptor antagonists for the management of postoperative pain. Ketamine exerts its main analgesic effect by antagonism of NMDA receptors that not only abolishes peripheral afferent noxious stimulation, but it may also prevent central sensitization of nociceptors as shown in animal studies with the excellent analgesic property even in subanesthetic doses. (6) Various recently published studies have talked about the analgesic effect of low-dose ketamine (7,8) however, all of this study are relatively short procedure time, reduced surgical stimulation and small sample size. The aim of this study is to evaluate the efficacy of intravenous low dose ketamine infusion versus morphine infusion analgesia for pain reduction in Abdominoplasty surgery

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: ketamine versus morphine
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Low-Dose Ketamine Infusion or Intravenous Morphine Infusion During Abdominoplasty Change Postoperative Pain Profile? : A Double-Blind, Randomized, Controlled Clinical Trial
Estimated Study Start Date : September 15, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : January 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: group K
patients with a ketamine infusion intraoperative
Drug: Ketamine
Ketamine group to whom intravenous ketamine was administered in a loading dose of 0.15 mg/kg over 5 min, 10 minutes pre incision, followed-by an infusion at 2 micg/kg/min until the end of surgery.
Other Name: Ketamine infusion

Experimental: group M
patients with a Morphine infusion intraoperative
Drug: Morphine
a loading dose of 0.1 mg/kg over 20 min intravenously, 10 minutes pre incision, then infused with morphine an infusion rate of 5 - 40 microgram/kg/hour till the end of surgery.
Other Name: Morphine infusion




Primary Outcome Measures :
  1. dose of fentanyl [ Time Frame: 4 hours ]
    Amount of fentanyl needed intraoperative and postoperative after extubation, and every hour postoperative for four hours.


Secondary Outcome Measures :
  1. pain assessment: VAS (Visual analogue scale) [ Time Frame: 4 hours ]
    Visual analogue scale for pain assessment.( VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom,pain,health) orientated from the left (worst) to the right (best). In some studies,horizontal scales are orientated from right to left ,and many investigators use vertical VAS.The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom,pain,health) orientated from the left (worst) to the right (best). In some studies,horizontal scales are orientated from right to left .


Other Outcome Measures:
  1. patient sedation (Ramsey Scale for assessment of patient sedation) [ Time Frame: 4 hours ]

    Anxious agitated and restless= 1 point

    • Cooperative, oriented and tranquil= 2 points
    • Responding only to verbal commands= 3 points
    • Brisk response to light glabella tap or loud auditory stimulus= 4points
    • Sluggish response to light glabella tap or loud auditory response= 5 points
    • No response to light glabella tap or loud auditory response= 6 points



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status I or II
  • patients aged between 18-50 years old. -

Exclusion Criteria:

  • those who refused to participate
  • ASA physical status III, IV, patients younger than 18 years or older than 50 years old
  • super morbid obesity with BMI 50, history of epilepsy
  • patients having a history of parenteral or oral analgesics within the last 24 hours before
  • initiation of operation
  • those having an allergy to study agents.

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): NCT03664622


Contacts
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Contact: hassan Ali 01001733687 hassan364@hotmail.com

Locations
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Egypt
Cairo University Recruiting
Cairo, Giza, Egypt, 1234
Contact: HASSAN M ALI, LECTURER    +201001733687    hassan364@hotmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: hassan Ali Cairo University

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Responsible Party: Hassan Mohamed Ali, associate professor, Cairo University
ClinicalTrials.gov Identifier: NCT03664622     History of Changes
Other Study ID Numbers: wahdan kteamine
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 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

Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Ketamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action