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
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain||Drug: Ketamine Drug: Morphine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||ketamine versus morphine|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
Experimental: group K
patients with a ketamine infusion intraoperative
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
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
- dose of fentanyl [ Time Frame: 4 hours ]Amount of fentanyl needed intraoperative and postoperative after extubation, and every hour postoperative for four hours.
- 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 .
- 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
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
|Contact: hassan Alifirstname.lastname@example.org|
|Cairo, Giza, Egypt, 1234|
|Contact: HASSAN M ALI, LECTURER +201001733687 email@example.com|
|Principal Investigator:||hassan Ali||Cairo University|