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Effect of a Topical Ketamine on Acute and Chronic Pain, Dose Finding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03165149
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Fatma Adel El sherif,MD, Assiut University

Tracking Information
First Submitted Date  ICMJE May 23, 2017
First Posted Date  ICMJE May 24, 2017
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2020)
the total amount of morphine consumption [ Time Frame: 48 hours ]
total amount of rescue analgesia
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
pain intensity [ Time Frame: 48 hours ]
pain intensity measured by Visual analogue scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2020)
pain intensity [ Time Frame: 48 hours ]
pain intensity measured by Visual analogue scale
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
sedation score [ Time Frame: 48 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of a Topical Ketamine on Acute and Chronic Pain, Dose Finding
Official Title  ICMJE Effect of a Topical Ketamine on Acute and Chronic Post-mastectomy Pain, Dose Finding - Clinical Study
Brief Summary The aim of this study is to investigate the effect of addition of different doses of Ketamine locally in acute and chronic post-mastectomy pain after breast cancer surgery and on the probability of developing chronic post-mastectomy pain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: group (A)
    patients will receive 1mg / kg of Ketamine diluted by 20 ml saline (0.9 % ) and irrigated onto surgical field after hemostats and before skin closure.
  • Drug: group (B)
    patients will receive 2 mg /kg of Ketamine diluted by 20 ml saline (0.9 %) and irrigated onto surgical field after hemostasis and before skin closure.
  • Drug: group (c)
    patients will receive 3 mg /kg of Ketamine diluted by 20 ml saline (0.9 %) and irrigated onto surgical field after hemostasis and before skin closure.
Study Arms  ICMJE
  • Active Comparator: Group (A)
    patients will receive 1mg / kg of Ketamine diluted by 20 ml saline (0.9 % )
    Intervention: Drug: group (A)
  • Active Comparator: Group (B)
    patients will receive 2 mg /kg of Ketamine diluted by 20 ml saline (0.9 %) a
    Intervention: Drug: group (B)
  • Active Comparator: Group (C)
    patients will receive 3 mg / kg of Ketamine diluted by 20 ml saline (0.9 %)
    Intervention: Drug: group (c)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2017)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2020
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- American society of heart association class I-II female patients

  • aged 18-60 years
  • scheduled for modified radical mastectomy with axillary dissection for breast carcinoma

Exclusion Criteria:

  • known allergy to the study drugs
  • significant cardiac-
  • respiratory-
  • renal or hepatic disease
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03165149
Other Study ID Numbers  ICMJE 17100205
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fatma Adel El sherif,MD, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP