Guanfacine for PONV and Pain After Sinus Surgery

Pain, Postoperative Clinical Trial

Official title:

Guanfacine for PONV and Pain After Sinus Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02882854
• Other study ID #: 160282
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: February 2017

Study information

• Verified date: December 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Guanfacine
Patients will receive 1 mg of guanfacine to take orally.
• Placebo
Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	15 minutes after arriving in PACU
Primary	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	30 minutes after arriving in PACU
Primary	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	60 minutes after arriving in PACU
Primary	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.	24 hours post op
Secondary	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	15, 30, 60 minutes after arriving in PACU
Secondary	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	24 hours postop
Secondary	Total Narcotic Requirement in PACU	Total narcotic requirement in PACU tallied in morphine equivalents during PACU stay	Time frame between arrival and discharge in PACU, approximately 90 minutes
Secondary	Number of Doses of PONV Treatment Administered in PACU		Time frame between arrival and discharge in PACU, approximately 90 minutes
Secondary	PACU Length of Stay in Minutes		Time frame between arrival and discharge in PACU, approximately 90 minutes