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Local Ketamine Instillation for Postoperative Analgesia

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: NCT02642497
Recruitment Status : Completed
First Posted : December 30, 2015
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmad Mohammad Abd El-Rahman, Assiut University

Tracking Information
First Submitted Date  ICMJE December 24, 2015
First Posted Date  ICMJE December 30, 2015
Last Update Posted Date January 4, 2017
Study Start Date  ICMJE August 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2016)
total opioid consumption [ Time Frame: 24 hours ]
the total amount of morphine consumed during follow up period
Original Primary Outcome Measures  ICMJE
 (submitted: December 29, 2015)
VAS [ Time Frame: 24 hours ]
effect of study drugs on postoperative pain measured by VAS score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2016)
  • first request of analgesia [ Time Frame: 24 hours ]
    time to first request of rescue analgesic drug
  • VAS [ Time Frame: 24 hours ]
    effect of study drugs on postoperative pain measured by VAS score
Original Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2015)
  • first request of analgesia [ Time Frame: 24 hours ]
    time to first request of rescue analgesic drug
  • total opioid consumption [ Time Frame: 24 hours ]
    the total amount of morphine consumed during follow up period
Current Other Pre-specified Outcome Measures
 (submitted: December 29, 2015)
possible side effects [ Time Frame: 24 hours ]
occurrence of possible side effects during follow up
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Local Ketamine Instillation for Postoperative Analgesia
Official Title  ICMJE Efficacy of Postoperative Analgesia Offered by Local Ketamine Wound Instillation Following Total Thyroidctomy; a Randomized, Double-blind, Controlled-clinical Trial
Brief Summary This study aims at exploring the analgesic efficacy, and safety of Ketamine instillation into the wound of total thyroidectomy compared to placebo,and to systemic ketamine administration (I.M. injection of the same dose) with respect to postoperative VAS, first request of analgesia, total opioid consumption, and with respect to possible side effects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: intra-wound instillation of ketamine
    intra-wound instillation of ketamine (1 mg/ kg) and normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure
  • Drug: intra-wound instillation of normal saline
    intra-wound instillation of normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure
    Other Name: placebo
  • Drug: systemic administration of ketamine
    intra-muscular administration of ketamine (1 mg/ kg), given before wound closure.
Study Arms  ICMJE
  • Active Comparator: local ketamine group
    intra-wound instillation of ketamine (1 mg/ kg) and normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure, with closure of suction drain tube for 30 min. postoperatively.
    Intervention: Drug: intra-wound instillation of ketamine
  • Placebo Comparator: control group
    intra-wound instillation of normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure, with closure of suction drain tube for 30 min. postoperatively.
    Intervention: Drug: intra-wound instillation of normal saline
  • Active Comparator: systemic ketamine group
    Intra-muscular injection of ketamine at a dose of 1 mg/kg before wound closure.
    Intervention: Drug: systemic administration of ketamine
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: January 1, 2017)
90
Original Actual Enrollment  ICMJE
 (submitted: December 29, 2015)
40
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with thyroid cancer scheduled for total thyroidectomy.

Exclusion Criteria:

  1. BMI>35
  2. Unstable ischaemic cardiac disease
  3. Increased intracranial pressure
  4. Increased intraocular pressure
  5. Hypersensitivity or allergy to ketamine, local anesthetic, morphine, or other drugs used in the study.
  6. Severe psychiatric disease
  7. Unwillingness or inability to use PCA-device
  8. Inability to use VAS scale
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02642497
Other Study ID Numbers  ICMJE 342
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ahmad Mohammad Abd El-Rahman, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date January 2017

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