Ketamine Versus Morphine Change Pain Profile

NCT03664622 | Completed

• 1 other identifier: wahdan kteamine
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• dose of fentanyl

  Amount of fentanyl needed intraoperative and postoperative after extubation, and every hour postoperative for four hours.

  4 hours

Secondary Outcomes (1)

• pain assessment: VAS (Visual analogue scale)

  4 hours

Other Outcomes (1)

• patient sedation (Ramsey Scale for assessment of patient sedation)

  4 hours

Study Arms (2)

group K

EXPERIMENTAL

patients with a ketamine infusion intraoperative

Drug: Ketamine

group M

EXPERIMENTAL

patients with a Morphine infusion intraoperative

Drug: Morphine

Interventions

Ketamine 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.

Also known as: Ketamine infusion

group K

Morphine 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.

Also known as: Morphine infusion

group M

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I or II
• patients aged between 18-50 years old. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 1234, Egypt

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Ketamine; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• hassan Ali

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: ketamine versus morphine

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: September 15, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 20, 2020
• Last Updated: June 29, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)