Post Operative Nausea and Vomiting, Rescue Emetic Therapy
Conditions
Keywords
PONV, Post operative nausea and vomiting, rescue emetic therapy
Brief summary
To compare ondansetron, metoclopramide, diphenhydramine, and placebo in order to determine which anti-emetic is most efficacious as a rescue therapy for pediatric patients ages 3-18 who have post-operative vomiting after a standardized prophylactic regimen of ondansetron and dexamethasone. We hypothesize that anti-emetics with a different mechanism of action than the prophylactic regimen will be the most effective rescue therapy in children having surgery in an ambulatory surgery center. 1. Problem: Despite commonly-used anti-emetics for prophylaxis, some children still go on to develop post-operative vomiting (POV). Goal: To determine which anti-emetic--ondansetron, metoclopramide, diphenhydramine, or placebo--is most efficacious for pediatric patients in this situation. 2. Hypothesis: Anti-emetic medications that have a different mechanism of action than the prophylactic regimen will be the most efficacious rescue therapy. 3. Hypothesis: Metoclopramide at the dose of 0.5 mg/kg (max dose 20 mg) will be more effective than ondansetron, diphenhydramine, or placebo as rescue therapy.
Interventions
DRUGMetaclopramide
0.5 mg/kg for rescue after PONV
DRUGOndansetron
0.1 mg/kg (max 4 mg0
DRUGdiphenhydramine
0.25 mg/kg (max 25 mg)
DRUGSaline
equal volume (5 ml)as experimental rescue medications
Sponsors
Franklyn Cladis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
1. Pediatric patients 3-17 years old 2. Patients scheduled for tonsillectomy and/or adenoidectomy (with and without myringotomy) , or dental restoration, 3. Patients receiving a general anesthetic (inhaled agent without nitrous oxide) with POV prophylaxis with two agents (ondansetron and dexamethasone) 4. Post operative vomiting in PACU or second stage recovery requiring antiemetic rescue.
Exclusion criteria
1. Vomiting in the past 24 hours or antiemetics in previous 24 hours 2. Allergy or sensitivity to ondansetron, dexamethasone, metoclopramide, or diphenhydramine 3. Patients with diabetes 4. Patients with seizures 5. Patients receiving a benzodiazepine premedication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary-Incidence of POV after rescue antiemetic in PACU, car ride home, day of surgery, and POD #1 and 2 | 48 hrs |
Secondary
| Measure | Time frame |
|---|---|
| Secondary - a. Discharge times | 48 hrs |
| Adverse events (headaches, sedation, dystonic reaction, dry mouth) | 48 hrs |
| POV risk factors. age, personal or family history of PONV, history of motion sickness, personal or family history of smoking | 48 hrs |
Countries
United States
Outcome results
None listed