Efficacy of Low Dose Promethazine for Postoperative Nausea and Vomiting
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|ClinicalTrials.gov Identifier: NCT01159548|
Recruitment Status : Terminated (Population of interest was no longer available)
First Posted : July 9, 2010
Last Update Posted : July 27, 2011
There has been an increase in ambulatory surgical procedures performed across Canada; ambulatory procedures account for almost 70% of all surgeries. Postoperative nausea and vomiting (PONV) and pain are the most frequently reported adverse events by patients prior to discharge after ambulatory surgery. The incidence can be as high as 70 to 80% in high-risk patients.
PONV is a cause of morbidity particularly in gynecological procedures and the incidence of patients experiencing PONV is as high as 58-75%. Apart from delayed recovery, the occurrence of PONV has been linked to gastric aspiration, psychological distress and wound dehiscence. The occurrence of PONV delays patient discharge and further more is a leading cause of unexpected admission after ambulatory anesthesia
Promethazine, is an antiemetic medication that has been widely used over the last 50 years, and although effective at reducing PONV, it tends to cause sedation. In this study, we are trying to determine if a smaller dose of promethazine, in addition to the standard treatment for post-surgical nausea and vomiting, will be more beneficial than the standard treatment on its own.
It is hypothesized that the use of low dose promethazine (3 mg) as part of a multimodal antiemetic regimen will be efficacious in preventing PONV without the sedative effects of promethazine.
|Condition or disease||Intervention/treatment|
|Ambulatory Gynecological Laparoscopic Procedures||Drug: Promethazine|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||July 2012|
|Estimated Study Completion Date :||July 2012|
|No Intervention: Saline|
|Promethazine 6.25 mg||Drug: Promethazine|
|Promethazine 3 mg||Drug: Promethazine|
- Absence of emetic episode for 24 h in the postoperative period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159548
|Women's College Hospital|
|Toronto, Ontario, Canada, M5S 1B2|
|Principal Investigator:||Jean Kronberg, MD, PhD||Women's College Hospital|