N/A
N=84
Guanfacine for PONV and Pain After Sinus Surgery
Postoperative Nausea and Vomiting · Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT02882854 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Comparison of PONV Score of Assessments Done at 15 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS) — 35; 33; 1; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Guanfacine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of PONV Score of Assessments Done at 15 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS) |
35; 33; 1; 2; 3; 4 | — |
| PRIMARY Comparison of PONV Score of Assessments Done at 30 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS) |
34; 34; 4; 5; 1; 2 | — |
| PRIMARY Comparison of PONV Score of Assessments Done at 60 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS) |
33; 35; 2; 5; 3; 1 | — |
| PRIMARY Postoperative Nausea Assessment Using 11-point Nausea Scale (nVRS) |
0.00; 0.00 | — |
| SECONDARY Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS) |
31; 24; 0; 5; 8; 10 | — |
| SECONDARY Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS) |
3; 2 | — |
| SECONDARY Total Narcotic Requirement in PACU |
8.75; 7.50 | — |
| SECONDARY Number of Doses of PONV Treatment Administered in PACU |
26; 32; 8; 5; 4; 3 | — |
| SECONDARY PACU Length of Stay in Minutes |
128; 110 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02882854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.