Ketamine Versus Morphine Change Pain Profile

NCT ID: NCT03664622

Last Updated: 2020-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-15
• Study Completion Date: 2020-01-20

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

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

group K

patients with a ketamine infusion intraoperative

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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.

group M

patients with a Morphine infusion intraoperative

Group Type: EXPERIMENTAL

Morphine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Ketamine infusion; Morphine infusion

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hassan Mohamed Ali

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hassan Ali

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo University

Cairo, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

wahdan kteamine

Identifier Type: -

Identifier Source: org_study_id