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Ketamine Versus Morphine Change Pain Profile

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ClinicalTrials.gov Identifier: NCT03664622
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Hassan Mohamed Ali, Cairo University

Tracking Information
First Submitted Date  ICMJE September 6, 2018
First Posted Date  ICMJE September 10, 2018
Last Update Posted Date June 29, 2020
Actual Study Start Date  ICMJE September 15, 2018
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
dose of fentanyl [ Time Frame: 4 hours ]
Amount of fentanyl needed intraoperative and postoperative after extubation, and every hour postoperative for four hours.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
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 .
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 7, 2018)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Ketamine Versus Morphine Change Pain Profile
Official Title  ICMJE Does Low-Dose Ketamine Infusion or Intravenous Morphine Infusion During Abdominoplasty Change Postoperative Pain Profile? : A Double-Blind, Randomized, Controlled Clinical Trial
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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
ketamine versus morphine
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Pain
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: group K
    patients with a ketamine infusion intraoperative
    Intervention: Drug: Ketamine
  • Experimental: group M
    patients with a Morphine infusion intraoperative
    Intervention: Drug: Morphine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2020)
160
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2018)
80
Actual Study Completion Date  ICMJE January 20, 2020
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03664622
Other Study ID Numbers  ICMJE wahdan kteamine
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hassan Mohamed Ali, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: hassan Ali Cairo University
PRS Account Cairo University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP