Ketamine Clinical Trial
Official title:
PCA Ketamine-Morphine Versus PCA Morphine as Post-Operative Analgesia in Colorectal Surgery.
Verified date | August 2023 |
Source | National University of Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clinical trial is to compare the effectiveness of PCA ketamine-morphine versus conventional PCA morphine in postoperative patients undergoing elective laparotomy colorectal surgery under general anaesthesia. The specific objectives are: 1. To compare the postoperative analgesic requirement with PCA ketamine-morphine in comparison with PCA morphine. 2. To compare the postoperative pain scores between PCA ketamine-morphine and PCA morphine. 3. To assess patients' overall satisfaction with PCA ketamine-morphine in comparison with PCA morphine. 4. To study the incidence of side effects of PCA ketamine-morphine in comparison with PCA morphine. Participants will be screened and recruited at the pre-anaesthetic clinic (PAC). Those who consented will be taught to use the PCA machine and the potential side effects of the study drugs. They will be randomly allocated into either Group A or Group B by computer-generated randomization a day before planned surgery. Researchers will compare Group A and Group B to see post-operative pain scores, patients' overall satisfaction and any incidence of side effects.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 4, 2019 |
Est. primary completion date | April 4, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. American Society of Anesthesiologists (ASA) I or II patients. 2. Patients between 18- 70 years of age. 3. Patients undergoing elective laparotomy colorectal surgery. Exclusion Criteria: 1. Patients with a known allergy to morphine or ketamine. 2. Patients with uncontrolled hypertension. 3. Patients with a past history of chronic pain on regular analgesics. 4. Patients on psychiatric drugs. 5. Patients with BMI more than 35. 6. Patients with Creatinine Clearance < 30 |
Country | Name | City | State |
---|---|---|---|
Malaysia | Universiti Kebangsaan Malaysia Medical Centre | Kuala Lumpur | Wilayah Persekutuan |
Lead Sponsor | Collaborator |
---|---|
National University of Malaysia |
Malaysia,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PCA drugs demanded and delivered | Total PCA drugs demanded and delivered | 30 minutes after commencement of PCA until 48 hours | |
Primary | Pain score | Pain score at rest and on movement with NRS
Numerical Rating Scale (NRS) for pain score assessment A numerical pain assessment tool from 0 to 10, where 0 denotes no pain, 5 denotes moderate pain and 10 denotes worst possible pain. |
30 minutes after commencement of PCA until 48 hours | |
Primary | Incidence of side effects | Opiod related side effects : nausea and vomiting, pruritus, dizziness, respiratory depression and treatment on PRN basis if indicated Ketamine related side effects : delirium, hallucinations, hypertension, tachycardia | 30 minutes after commencement of PCA until 48 hours | |
Primary | Patients' overall satisfaction | Assessment of patients' overall satisfaction with a 5-points scales at 48 hours.
A 5-point scale from 1 to 5, where: very unsatisfied unsatisfied neutral satisfied very satisfied |
At 48 hours post operative |
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