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NCT05341323 Clinical Trial

Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia

Post Operative Pain Clinical Trial

Official title:
Comparison Between Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05341323
Other study ID # Soh_Med_22_02_07
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2, 2022
Est. completion date July 2, 2022

Study information
Verified date July 2022
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date July 2, 2022
Est. primary completion date July 2, 2022
Accepts healthy volunteers No
Gender All
Age group 3 Years to 20 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ketamine.
Peritonsillar infiltration of ketamine
• Bupivacaine
peritonsillar infiltration of Bupivacaine

Locations
Country Name City State
Egypt Sohag Faculty of Medicine Sohag

Sponsors (1)
Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative pain The pain will be assessed using modi?ed 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 60 minutes postoperatively
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