Clinical trial NCT05024825: Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy
Official title: Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: tonsillectomy
gabapentin
postoperative pain
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 17
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine if administration of gabapentin preoperatively followed by a standing postoperative course is effective in reducing and possibly eliminating the use of opioid analgesics following this procedure. As a secondary outcome, it will evaluate the possible improvement in post tonsillectomy pain control with the use of a standing dose of gabapentin.

Detailed description: This is a prospective, randomized, non-blinded control trial designed to determine if administration of gabapentin postoperatively is effective in reducing and possibly eliminating the use of opioid analgesics following tonsillectomies in the adolescent population.

Eligibility criteria: Inclusion Criteria:

* Patients aged 12-18.
* Patient scheduled for elective tonsillectomy +/- adenoidec-tomy, +/- BMTs.
* ASA physical status I and II.

Exclusion Criteria:

* Severe upper respiratory tract infections.
* Patients who are actively on gabapentin or pregabalin, pre-existing with pain syndromes, chronic use of opioids, allergy to gabapentin, acetaminophen, and or NSAIDs
* Patient who lacks of fluency in English or inability to communicate pain.
* Patient who has severe asthma, bleeding disorders, and history of gastrointestinal bleeding, epilepsy, renal impairment or any other medical problem that in the opinion of the investigator would interfere with study population.

Primary outcomes:
measure: Total opioid equivalent dose
timeFrame: Through completion of the study. Time frame per subject is 7 days.
Secondary outcomes:
measure: Post operative pain score determined by Visual Analog Survey Scale
timeFrame: Through completion of the study. Time frame per subject is 7 days.
measure: Medication Adverse Effect
timeFrame: Through completion of the study. Time frame per subject is 7 days.
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
References:
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