Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia

Sohag University

Status and phase: Completed; Phase 4

Conditions: Post Operative Pain

Treatments: Drug: Bupivacaine; Drug: Ketamine.

Study type: Interventional

Funder types: Other

Identifiers

NCT05341323

Soh_Med_22_02_07

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 3 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

80 participants in 2 patient groups

Group K1 Ketamine

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine.

Group B1 Bupivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine