Ketamine Versus Morphine Change Pain Profile
Primary Purpose
Acute Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility 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.
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group K
group M
Arm Description
patients with a ketamine infusion intraoperative
patients with a Morphine infusion intraoperative
Outcomes
Primary Outcome Measures
dose of fentanyl
Amount of fentanyl needed intraoperative and postoperative after extubation, and every hour postoperative for four hours.
Secondary Outcome Measures
pain assessment: VAS (Visual analogue scale)
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 .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03664622
Brief Title
Ketamine Versus Morphine Change Pain Profile
Official Title
Does Low-Dose Ketamine Infusion or Intravenous Morphine Infusion During Abdominoplasty Change Postoperative Pain Profile? : A Double-Blind, Randomized, Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
ketamine versus morphine
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group K
Arm Type
Experimental
Arm Description
patients with a ketamine infusion intraoperative
Arm Title
group M
Arm Type
Experimental
Arm Description
patients with a Morphine infusion intraoperative
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketamine infusion
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Morphine infusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
dose of fentanyl
Description
Amount of fentanyl needed intraoperative and postoperative after extubation, and every hour postoperative for four hours.
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
pain assessment: VAS (Visual analogue scale)
Description
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 .
Time Frame
4 hours
Other Pre-specified Outcome Measures:
Title
patient sedation (Ramsey Scale for assessment of patient sedation)
Description
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
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hassan Ali
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
State/Province
Giza
ZIP/Postal Code
1234
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Ketamine Versus Morphine Change Pain Profile
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