On a comparative basis, use of the Pressure Right® acupressure device with ondansetron and dexamethasone was more reliable in PONV management effectiveness than the antiemetic drugs alone
Evidence-based study finds adjunctive use of Pressure Right® device enhanced the efficacy of the most commonly used prophylactic antiemetic drug combination
Grand Rapids, Mich – In a peer-reviewed published study, a new medically engineered pressure-technology disposable adhesive device (Pressure Right®) developed by Pressure Point Inc. has clinically proven to enhance the efficacy of a popular prophylactic antiemetic drug combination in reducing the incidence of postoperative nausea and vomiting (PONV) among high-risk patients after major laparoscopic surgery procedures. PONV is estimated to affect a minimum of 30% of the adult surgical population in the U.S. due to certain risk factors, despite the widespread use of prophylactic antiemetics, according to research experts. In high-risk surgery patients, the incidence of PONV is estimated to be significantly higher.
In analyzing this peer-reviewed, randomized, double-blinded, sham-controlled study appearing in the Anesthesia-Analgesia Journal last month, 84% of patients in the experimental group were found to be highly satisfied with their overall (PONV) management using Pressure Right® as an adjunct to a routine antiemetic drug combination. This compared to 66% of patients in the control group being satisfied which used a sham device as an adjunct to the same antiemetic drug combination. The study consisted of PONV at-risk patients undergoing major laparoscopic procedures which were assessed at 72 hours postoperatively to determine differences in patient satisfaction outcomes.
The Pressure Right® sham-controlled study (Use of a Disposable Acupressure Device) conducted by the White PF group evaluated several clinical endpoints to assess the device's adjunct effectiveness as part of a multimodal antiemetic strategy for reducing postoperative nausea and vomiting. The study method included 100 ASA physical I and II patients divided evenly into two study groups: Pressure Right group (50) patients received the Pressure Right® device and the control group (50) patients received a sham device. Each patient was randomly assigned to either group. Both study groups received antiemetic therapy consisting of ondansetron, 4 mg IV, and dexamethasone, 4 mg. IV, and did not differ in their demographic characteristics or risk factors for PONV. All patients received a standardized general anesthetic.
As indicated as follows, the study endpoint results clearly support the use of Pressure Right® as a primary intervention tool in preventing PONV in high-risk patients.
The emesis (vomiting) results showed that 88% of the Pressure Right patients did not experience emesis compared to 70% in the study control group in the 0 to 72 hour postoperative period.
Another important antiemetic measurement known as the complete response rate for PONV outcomes (CR), (as the absence of any emesis or retching and no need for antiemetic rescue medication) to prophylactic treatment was 72% vs. 54% for the Pressure Right group vs. the control group, respectively, over the 72 hour postoperative study period.
An additional measurement rate known as the complete control (CC) rate for measuring PONV (CC plus no nausea) outcomes, resulted in an effective rate of 54% for (Pressure Right®) versus 42% for the (Control Group). According to the author of this study, the reported results may have been related to the insensitive method used to assess postoperative nausea. The method used was a binary (Yes or No) response, rather than on a more conventional analog (11 point) verbal rating scale (none, mild, moderate or severe). The latter approach is generally known to produce a more factual measurement in assessing the severity of nausea in study patients.
With the exception of the (CC) study measurement, all of the other study measurements achieved statistical significance or closely approached statistical significance within (1%) of the power analysis study design.
The Pressure Right® study power analysis (α= 0.05, β= 80%) was performed before the initiation of the study. The analysis suggested that the group sizes were adequate to detect a 25% to 30% absolute decrease in the number of patients experiencing PONV symptoms in the Pressure Right group compared to the control group taking into consideration a 65% incidence in these at-risk surgery patients undergoing major laparoscopic procedures.
As an adjunct to antiemetic (prophylactic) drug combinations, Pressure Right® continues to show better outcomes of overall PONV prevention in hospitals and surgery centers, compared to standard practice antiemetic prophylactic combinations.
The peer-reviewed research results of the Pressure Right® study effectively demonstrates that with the addition of this disposable acupressure (adhesive) device as part of a routine antiemetic strategy, its enhancement effect can be a major step forward in reducing the effects of PONV for patients at-risk.
Pressure Point Inc. achieved 510(k) premarket notification clearance from the US Food and Drug Administration for Pressure Right® in April 2011. Pressure Right® is intended to be applied bi-laterally to patients' wrists prior to the induction of anesthesia with no adverse effects.
Ask us how we can help in reducing the effects of nausea and vomiting as well as the need for rescue antiemetic therapy drugs.
Contact information:
Joseph DiLustro
Chairman & CEO
Pressure Point Inc.
Tel: (908) 601-8877
Web site: www.pressurerightstrip.com
Email: therapeutics101@verizon.net
Journal
Anesthesia & Analgesia