Guanfacine for PONV and Pain After Sinus Surgery

Vanderbilt University Medical Center84 enrolled

Overview

Postoperative nausea and vomiting (PONV) and pain are the most common causes of Post Anesthesia Care Unit (PACU) discharge delay, with untreated PONV occurring in 20-30% of post-surgical patients. The effect of guanfacine (GF) administration on pain and nausea scores will be assessed with two groups. One group will receive 1 mg of GF to take orally and the other group will receive a similar appearing placebo (containing no drug) to take orally.

Pain after surgery is commonly treated with narcotics which can potentiate PONV, further delaying PACU discharge. In multiple studies, alpha-2 agonists such as clonidine and dexmedetomidine reduce both the incidence of PONV and post-op pain, as well as requirements for postoperative analgesics. These actions are mediated via central alpha-2A receptors (A2AR). Of the A2AR agonists, guanfacine, though a weak antihypertensive agent, has the highest selectivity for the A2AR, but to date is untested for its potential to treat either PONV or post-operative pain.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Postoperative Nausea and Vomiting Pain, Postoperative

Interventions

GuanfacineDRUG

Patients will receive 1 mg of guanfacine to take orally.

PlaceboDRUG

Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * VUMC patients undergoing sinus surgery in MCE OR Exclusion Criteria: * Inability to read and freely consent * Patients who take alpha-2 agonists routinely (guanfacine, clonidine, tizanidine) * Patients undergoing sinus surgery planned for greater than 3 hours * Patients with significant pre-existing pain, on chronic pain (opioid, methadone) therapy, severe fibromyalgia or other pre-existing pain condition in any body part * Patients with preoperative nausea/vomiting at baseline. * Pregnant or lactating women

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Comparison of PONV Score of Assessments Done at 15 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)

Comparison of PONV Score of assessments done at 15 minutes after arrival in PACU using the nVRS when 0 is no nausea and 10 is worst nausea

Time frame: 15 minutes after arriving in PACU

Comparison of PONV Score of Assessments Done at 30 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)

Comparison of PONV Score of assessments done at 30 minutes after arrival in PACU using the nVRS when 0 is no nausea and 10 is worst nausea

Time frame: 30 minutes after arriving in PACU

Comparison of PONV Score of Assessments Done at 60 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)

Comparison of PONV Score of assessments done at 60 minutes after arrival in PACU using the nVRS when 0 is no nausea and 10 is worst nausea

Time frame: 60 minutes after arriving in PACU

Postoperative Nausea Assessment Using 11-point Nausea Scale (nVRS)

PONV assessed using nVRS at 24 hours postop when 0 is no nausea and 10 is worst nausea.

Time frame: 24 hours post op

Secondary Outcomes

Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)

Maximum postoperative pain assessment assessed in PACU at 15, 30 and 60 minutes after PACU arrival using VAS when 0 is no pain and 10 is worst pain

Time frame: 15, 30, 60 minutes after arriving in PACU

Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)

Postoperative pain assessment using VAS at 24 hours postop when 0 is no pain and 10 is worst pain

Data from ClinicalTrials.gov

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