Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia

NCT ID: NCT05341323

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-02

Study Completion Date

2022-07-02

Brief Summary

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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

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Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group K1 Ketamine

pre-incisional submucosal infiltration of ketamine .5 mg/kg in the Peritonsillar area

Group Type ACTIVE_COMPARATOR

Ketamine.

Intervention Type DRUG

Peritonsillar infiltration of ketamine

Group B1 Bupivacaine

pre-incisional submucosal infiltration of Bupivacaine .25 % in the Peritonsillar area

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

peritonsillar infiltration of Bupivacaine

Interventions

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Ketamine.

Peritonsillar infiltration of ketamine

Intervention Type DRUG

Bupivacaine

peritonsillar infiltration of Bupivacaine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Abdallah Abozaid

Resident doctor at otorhinolaryngiology, head and neck surgery department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ibrahem Risk, Professor

Role: STUDY_DIRECTOR

Professor of ENT

Osama Elshrief, Professor

Role: STUDY_CHAIR

Dean of Faculty of Medicine

Locations

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Sohag Faculty of Medicine

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Soh_Med_22_02_07

Identifier Type: -

Identifier Source: org_study_id

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