Ondansetron/promethazine combination or promethazine alone reduces nausea and vomiting after middle ear surgery.
OBJECTIVE
To determine the incidence of postoperative nausea and vomiting when a combination of ondansetron and promethazine is given prophylactically, and to ascertain the effect of postoperative nausea and vomiting on recovery room duration and patient satisfaction.


METHODS
Prospective, randomized, placebo-controlled, double-blind study.


METHODS
University-affiliated tertiary-care hospital.


METHODS
87 ASA physical status I and II adult patients scheduled for middle ear surgery.


METHODS
Patients were randomly assigned to receive one of the following interventions intravenously: ondansetron 4 mg (Group 1), promethazine 25 mg (Group 2), ondansetron 2 mg plus promethazine 12.5 mg (Group 3, combination), or placebo (Group 4).


RESULTS
Independent, study blinded observers recorded complaints of nausea and number of episodes of vomiting for 24 hours following the patient's first response to commands. All patients were contacted the day after discharge to inquire about nausea and vomiting. The awakening time, postanesthesia care unit and day surgery unit durations, opioid use, and side effects were recorded. At the end of the 24-hour period, the study blinded observers asked patients for an overall assessment of their global anesthesia experience using an 11-point scale. During the 24-hour period, the incidence of postoperative nausea and vomiting was reduced from 74% (placebo) to 39% (promethazine; p = 0.03) and 29% (combination; p = 0.003). Compared with placebo, the severity of vomiting was significantly less in the combination group (p = 0.04). The number of very satisfied patients correlated negatively with the incidence of postoperative nausea and vomiting (p < 0.0001) and with the severity of vomiting (p = 0.003).


CONCLUSIONS
The prophylactic use of an antiemetic with middle ear surgery may reduce postoperative nausea and vomiting over 24 hours, and the ondansetron/promethazine combination or promethazine alone are cost-effective choices. Finally, the combination reduced significantly the severity of vomiting.
Khalil
S
S
Department of Anesthesiology, University of Texas Medical School at Houston 77030, USA. skhalil@anes1.med.uth.tmc.edu
Philbrook
L
L
Rabb
M
M
Wells
L
L
Aves
T
T
Villanueva
G
G
Amhan
M
M
Chuang
A Z
AZ
Lemak
N A
NA
D000293:Adolescent; D000328:Adult; D000368:Aged; D000556:Ambulatory Surgical Procedures; D000701:Analgesics, Opioid / Q000627:therapeutic use; D000762:Anesthesia Recovery Period; D000932:Antiemetics / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004432:Ear, Middle / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D017294:Ondansetron / Q000008:administration & dosage / Q000627:therapeutic use*; D017060:Patient Satisfaction; D010919:Placebos; D020250:Postoperative Nausea and Vomiting / Q000517:prevention & control*; D011398:Promethazine / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies
D000701:Analgesics, Opioid; D000932:Antiemetics; D004338:Drug Combinations; D010919:Placebos; D017294:Ondansetron; D011398:Promethazine