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Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy 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: NCT05341323
Recruitment Status : Enrolling by invitation
First Posted : April 22, 2022
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
Mohamed Abdallah Abozaid, Sohag University

Tracking Information
First Submitted Date  ICMJE April 3, 2022
First Posted Date  ICMJE April 22, 2022
Last Update Posted Date April 22, 2022
Actual Study Start Date  ICMJE April 2, 2022
Estimated Primary Completion Date December 2, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2022)
Postoperative pain [ Time Frame: 60 minutes postoperatively ]
The pain will be assessed using modified Hannallah pain scale which includes blood pressure, movement, agitation and posture where zero is the least pain and 2 is the worest necessitating rescue analgesia
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia
Official Title  ICMJE Comparison Between Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia
Brief Summary Comparison between the analgesic effect of local infiltration of either Bupivacaine or ketamine in the peritonsillar area before the incision of tonsillectomy to achieve postoperative analgesia
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Post Operative Pain
Intervention  ICMJE
  • Drug: Ketamine.
    Peritonsillar infiltration of ketamine
  • Drug: Bupivacaine
    peritonsillar infiltration of Bupivacaine
Study Arms  ICMJE
  • Active Comparator: Group K1 Ketamine
    pre-incisional submucosal infiltration of ketamine .5 mg/kg in the Peritonsillar area
    Intervention: Drug: Ketamine.
  • Active Comparator: Group B1 Bupivacaine
    pre-incisional submucosal infiltration of Bupivacaine .25 % in the Peritonsillar area
    Intervention: Drug: Bupivacaine
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 Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: April 20, 2022)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2, 2023
Estimated Primary Completion Date December 2, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  • 3-20 years old patients
  • elective tonsillectomy or adenotonsillectomy with or without ventilation tube application.

Exclusion criteria

  • allergy to bupivacaine or ketamine
  • coagulopathy
  • endocrine, neuropsychiatric or cardiopulmonary dysfunction
  • increase intracranial pressure (ICP)
  • psychiatric illness, history of seizure, patients under chronic analgesic treatment
  • history of peritonsillar abscess, tonsillar malignancy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 20 Years   (Child, 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 NCT05341323
Other Study ID Numbers  ICMJE Soh_Med_22_02_07
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mohamed Abdallah Abozaid, Sohag University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sohag University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ibrahem Risk, Professor Professor of ENT
Study Chair: Osama Elshrief, Professor Dean of Faculty of Medicine
PRS Account Sohag University
Verification Date April 2022

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