Clinical trial NCT01067677: Rescue Emetic Therapy for Children Having Elective Surgery
Official title: Rescue Emetic Therapy for Children Having Elective Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post Operative Nausea and Vomiting
Rescue Emetic Therapy
Keywords: PONV
Post operative nausea and vomiting
rescue emetic therapy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2010-02-11
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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."


Eligibility criteria: 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

Primary outcomes:
measure: Primary-Incidence of POV after rescue antiemetic in PACU, car ride home, day of surgery, and POD #1 and 2
timeFrame: 48 hrs
Secondary outcomes:
measure: Secondary - a. Discharge times
timeFrame: 48 hrs
measure: Adverse events (headaches, sedation, dystonic reaction, dry mouth)
timeFrame: 48 hrs
measure: POV risk factors. age, personal or family history of PONV, history of motion sickness, personal or family history of smoking
timeFrame: 48 hrs
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: The Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Franklyn P Cladis, MD
role: PRINCIPAL_INVESTIGATOR
References: