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A Comparison of Two Differing Doses of Promethazine for the Treatment of Postoperative Nausea and Vomiting Christine L

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A Comparison of Two Differing Doses of Promethazine for the Treatment of Postoperative Nausea and Vomiting Christine L ORIGINAL ARTICLES A Comparison of Two Differing Doses of Promethazine for the Treatment of Postoperative Nausea and Vomiting Christine L. Deitrick, BS, RN, CAPA, Diane J. Mick, PhD, RN, FNAP, Vickie Lauffer, RN, BSN, Eloise Prostka, BS, RN, CPAN, Daniel Nowak, RN, MS, Gail Ingersoll, EdD, RN, FAAN, FNAP Purpose: To compare the use of promethazine 6.25 mg intravenous (IV) (experimental group) with promethazine 12.5 mg IV (control group) among adult ambulatory surgery patients to control established postop- erative nausea or vomiting (PONV). Design/Methods: In a double-blind, randomized controlled trial (n 5 120), 59 subjects received promethazine 6.25 mg and 61 subjects received prom- ethazine 12.5 mg to treat PONV.Study doses were administered postopera- tively if the subject reported/exhibited nausea and/or vomiting. Outcomes for experimental and control groups were compared on the basis of relief of PONV and sedation levels. Findings: Ninety-seven percent of subjects reported total relief of nausea with a single administration of promethazine at either dose. Sedation levels differed between groups at 30 minutes post-medication administra- tion and at the time of discharge to home. Conclusions: Promethazine 6.25 mg is as effective in controlling PONV as promethazine 12.5 mg, while resulting in less sedation. Keywords: ambulatory surgery, nausea and vomiting, promethazine, sedation, perianesthesia nursing, research, RCT. Ó 2015 by American Society of PeriAnesthesia Nurses ONE OF THE MOST COMMON adverse effects ticoids (dexamethasone), antihistamines (dimen- of surgery and anesthesia is postoperative hydrinate, cyclizine), cholinergic antagonists nausea and vomiting (PONV).1 These adverse (scopolamine patch), dopamine antagonist effects may persist despite administration of intra- (droperidol or haloperidol), metoclopramide, operative medications to prevent their occur- or neurokinin-1 receptor antagonists4 are used 2-4 rence. Various agents including 5-HT3 receptor to prevent or treat PONV, as is intravenous (IV) antagonists (ondansetron, granisetron), glucocor- promethazine. Christine L. Deitrick, BS, RN, CAPA, is a Level III Nurse, The study was funded by a combined Association of Strong Surgical Center, Strong Memorial Hospital, Rochester, periOperative Registered Nurses (AORN) and Sigma Theta NY; Diane J. Mick, PhD, RN, FNAP, Associate Professor, Keuka Tau International Small Grant. College, Keuka Park, NY; Vickie Lauffer, RN, BSN, Project Conflict of interest: None to report. Nurse, Center for Employee Wellness, Strong Memorial Hospi- Address correspondence to Christine L. Deitrick, Strong Sur- tal, Rochester, NY; Eloise Prostka, BS, RN, CPAN, Staff Nurse, gical Center,Strong Memorial Hospital, 601 Elmwood Avenue, Post Anesthesia Care Unit, Strong Memorial Hospital, Roches- Rochester, NY 14642; e-mail address: Christine_Deitrick@ ter, NY; Daniel Nowak, RN, MS, NEA-BC, Nurse Manager, Ko- urmc.rochester.edu. nar Center for Digestive and Liver Disease, Strong Memorial Ó 2015 by American Society of PeriAnesthesia Nurses Hospital, Rochester, NY; and Gail Ingersoll, EdD, RN, FAAN, 1089-9472/$36.00 FNAP, Professor, School of Nursing, University of Rochester http://dx.doi.org/10.1016/j.jopan.2014.01.009 Medical Center, Rochester, NY (deceased). Journal of PeriAnesthesia Nursing, Vol 30, No 1 (February), 2015: pp 5-13 5 6 DEITRICK ET AL Promethazine is a phenothiazine derivative that on direct clinical experience and direct observa- competitively blocks histamine (H [1]) receptors tion of adult ambulatory surgery patients over and exhibits anti-emetic and sedative properties.5 time by Phase I and Phase II (ambulatory surgical Relief of PONV typically is achieved within 5 mi- center) nurses, the following specific aims were nutes of IV infusion of promethazine6 and lasts generated: for 2 to 6 hours.5 The major drawback to the use 1. To compare the effects of two different of promethazine for ambulatory surgery patients doses of promethazine (6.25 mg IV vs is its sedating effect.6 12.5 mg IV) on PONV in a sample of adult ambulatory surgery patients undergoing Any adverse reaction to medication, including elective surgery. sedation, delays patients’ postoperative recovery 2. To compare levels of postoperative sedation time,7 resulting in delayed ambulation and fluid between adult ambulatory surgery patients intake, increasing the need for nursing interven- who received promethazine 6.25 mg IV tion, and decreasing patient satisfaction. The (experimental group) vs promethazine possibility of delayed discharge is an added 12.5 mg IV (control group). inconvenience for both the patient and their family. Study Design Because of the sedating effect of promethazine, recommendations exist for the use of doses lower Between October 2008 and March 2011, a conve- than the current standard (12.5 to 25 mg) to nience sample of adult ambulatory surgical pa- achieve antiemetic relief.8,9 Although limited tients who were sent from the operating room research has been carried out related to (OR), per the determination of the anesthesiolo- promethazine dosing, some evidence exists for gist, to either Phase I or Phase II were randomized the administration of promethazine 6.25 mg in to receive promethazine 6.25 mg IV (experimental the presence of PONV. In a comparison of three group) or promethazine 12.5 mg IV (control IV doses (6.25, 12.5, and 25 mg), no differences group) if PONV were to occur. were found in the effectiveness of promethazine doses in treating PONV among patients (n 5 330) Setting in a post-anesthesia care unit (Phase I).10 In a similar comparison carried out among hospitalized The study was conducted at a 750-bed teaching elderly patients (n 5 26), no difference in relief of hospital in the Northeastern United States. symptoms was observed with the lower dose of promethazine (6.25 mg IV) for the treatment Preparation of Study Team of nausea and vomiting.11 Several investigators have examined the use of IV promethazine at doses Phase I and Phase II nurses responsible for data of either 12.5 or 25 mg for treatment of PONV11-14; collection were oriented to the study and sub- however, these studies compared IV promethazine ject enrollment procedures during educational with different classes of antiemetics or were sessions carried out by the investigators and sup- carried out in settings other than perianesthesia. ported by the institution’s Clinical Nursing Moreover, a review of current literature revealed Research Center. In these sessions, data collec- no studies that were focused on the use of tion instruments were reviewed and regulations promethazine 6.25 mg IV in the adult ambulatory concerning the protection of human subjects’ surgery population. rights were discussed. Copies of the consent form, data collection tool, study design, study Study Purpose kits, and visual descriptive scale were provided and discussed in detail. Laminated cue cards The purpose of this study was to compare two were posted in each area for reference, and a doses of IV promethazine (6.25 vs 12.5 mg) in a nurse investigator was available to answer ques- sample of adult ambulatory surgery subjects tions, address concerns, and monitor inter-rater (n 5 120) who were expected to be discharged reliability during data collection in both Phase I home after an elective surgical procedure. Based and Phase II areas. DIFFERING DOSES OF PROMETHAZINE 7 Sample nessed informed consent. Following consent, sub- jects were randomized to the experimental or The sample for this study was drawn from control group. A pharmacist who was not involved adult patients undergoing elective surgery and with the study served as data safety monitor and con- who were between the ages of 18 and 75 years. ducted independent checks of data to monitor for ev- Study inclusion criteria were elective urologic, idence of unsafe or adverse events that would neurologic, general surgery, thoracic, vascular, warrant discontinuation of the study. otolaryngology, orthopedic, oral maxillofacial, gynecologic, or colorectal surgery; English Instruments speaking; and able to consent to participate. Exclu- sion criteria were less than 18 years or older than Nausea Scale 75 years, pregnancy, breastfeeding, known allergy to promethazine, non-English speaking, and The investigators developed a verbal descriptive refusal or inability to sign study consent. Any pro- scale (VDS) to address subjects’ degree of spective subject with a sedation level greater than PONV. The tool assessed degree of nausea, vomit- ‘‘3’’ on the hospital’s internal sedation scale or who ing, or both, by the subject with or without the had limited IVaccess requiring IV placement in the assistance of the bedside Registered Nurse (re- lower extremities was excluded. Subjects also viewing the scale or asking the patient). were excluded if the attending surgeon did not Response options ranged from 1 (none) to 6 agree to enrollment of his or her patients or to (vomited repeatedly). Subjects were asked, by the planned use of promethazine by either surgeon their bedside nurse, to state, point, or indicate or anesthesiologist. No subject was excluded the whole number or words that described their because of gender, income, race, or religion. Sam- level of nausea or frequency of vomiting on the ple demographics are contained in Table 1. VDS scale. If, after one episode of vomiting, the nausea did not independently resolve without Method Used for Randomization intervention, the subjects were asked if they would like treatment (promethazine study dose) Using a computer-generated random numbers for any residual nausea. Clinical nursing observa- table, each subject was randomized to receive tion, over time, has revealed that PONV either promethazine 6.25 mg IV or promethazine frequently resolves, without intervention, after a 12.5 mg IV. Drug preparation and subject random- single episode of vomiting. ization were performed by the pharmacist mem- ber of the study team. The nurses administering Sedation Scale the promethazine dose and those collecting the study data were not aware of which dose was be- The investigators used the institution’s internal seda- ing administered to the subject.
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