Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: intra-wound instillation of ketamine Drug: intra-wound instillation of normal saline Drug: systemic administration of ketamine Phase 2 Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Postoperative Analgesia Offered by Local Ketamine Wound Instillation Following Total Thyroidctomy; a Randomized, Double-blind, Controlled-clinical Trial
Study Start Date : August 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 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
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.
 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
Active Comparator: systemic ketamine group
Intra-muscular injection of ketamine at a dose of 1 mg/kg before wound closure.
 Drug: systemic administration of ketamine
intra-muscular administration of ketamine (1 mg/ kg), given before wound closure.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. total opioid consumption [ Time Frame: 24 hours ]
    the total amount of morphine consumed during follow up period


Secondary Outcome Measures :
  1. first request of analgesia [ Time Frame: 24 hours ]
    time to first request of rescue analgesic drug

  2. VAS [ Time Frame: 24 hours ]
    effect of study drugs on postoperative pain measured by VAS score


Other Outcome Measures:
  1. possible side effects [ Time Frame: 24 hours ]
    occurrence of possible side effects during follow up


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ahmad Mohammad Abd El-Rahman, lecturer of anesthesia, ICU, and pain management, Assiut University
ClinicalTrials.gov Identifier: NCT02642497    
Other Study ID Numbers: 342
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ahmad Mohammad Abd El-Rahman, Assiut University:
postoperative analgesia
ketamine
total thyroidectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action