Post Operative Nausea and VomitingRETCHESNCT01067677
Rescue Emetic Therapy for Children Having Elective Surgery
A study testing Metaclopramide, Ondansetron and diphenhydramine in people with Post Operative Nausea and Vomiting and Rescue Emetic Therapy, run by Franklyn Cladis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Nausea and Vomiting, Rescue Emetic Therapy
- What is being tested?
- Metaclopramide, Ondansetron and diphenhydramine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pediatric patients 3-17 years old
- Patients scheduled for tonsillectomy and/or adenoidectomy (with and without myringotomy) , or dental restoration,
- Patients receiving a general anesthetic (inhaled agent without nitrous oxide) with POV prophylaxis with two agents (ondansetron and dexamethasone)
- Post operative vomiting in PACU or second stage recovery requiring antiemetic rescue.
Who cannot join
- Vomiting in the past 24 hours or antiemetics in previous 24 hours
- Allergy or sensitivity to ondansetron, dexamethasone, metoclopramide, or diphenhydramine
- Patients with diabetes
- Patients with seizures
- Patients receiving a benzodiazepine premedication
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15210
About this study
Official title: Rescue Emetic Therapy for Children Having Elective Therapy
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.
- 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.
- Hypothesis: Anti-emetic medications that have a different mechanism of action than the prophylactic regimen will be the most efficacious "rescue therapy."
- 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."
- Being tested
- Metaclopramide, Ondansetron, diphenhydramine, Saline
- Keywords
- PONV, Post operative nausea and vomiting, rescue emetic therapy
- Medical subject headings
- Vomiting, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetaclopramideDrug
0.5 mg/kg for rescue after PONV
OndansetronDrug
0.1 mg/kg (max 4 mg0
diphenhydramineDrug
0.25 mg/kg (max 25 mg)
SalineDrug
equal volume (5 ml)as experimental rescue medications
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide | Experimental | rescue emetic therapy Receives: Drug: Metaclopramide |
| Ondansetron | Experimental | Rescue emetic therapy Receives: Drug: Ondansetron |
| Diphenhydramine | Experimental | Rescue emetic therapy Receives: Drug: diphenhydramine |
| Saline | Placebo comparator | Placebo Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary-Incidence of POV after rescue antiemetic in PACU, car ride home, day of surgery, and POD #1 and 2
Measured: 48 hrs
Secondary outcomes (3)
Secondary - a. Discharge times
Measured: 48 hrs
Adverse events (headaches, sedation, dystonic reaction, dry mouth)
Measured: 48 hrs
POV risk factors. age, personal or family history of PONV, history of motion sickness, personal or family history of smoking
Measured: 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2014 (estimated)
Why it stopped: We do not have the funding or resources to complete the study at this time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franklyn Cladis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Franklyn Cladis, University of Pittsburgh
- Investigators
- Franklyn P Cladis, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067677
- Sponsor's protocol ID
- 1-Cladis
- Acronym
- RETCHES
- Status last verified
- Nov 2017
- First submitted
- 10 Feb 2010
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescue Emetic Therapy for Children Having Elective Therapy
- ClinicalTrials.gov ID
- NCT01067677
- Acronym / sponsor ID
- RETCHES / 1-Cladis
- Keywords
- PONV, Post operative nausea and vomiting, rescue emetic therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We do not have the funding or resources to complete the study at this time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Franklyn CladisUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 11 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- Hypothesis: Anti-emetic medications that have a different mechanism of action than the prophylactic regimen will be the most efficacious "rescue therapy."
- 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."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide | Experimental | Drug: Metaclopramiderescue emetic therapy |
| Ondansetron | Experimental | Drug: OndansetronRescue emetic therapy |
| Diphenhydramine | Experimental | Drug: diphenhydramineRescue emetic therapy |
| Saline | Placebo comparator | Drug: SalinePlacebo |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pediatric patients 3-17 years old
- Patients scheduled for tonsillectomy and/or adenoidectomy (with and without myringotomy) , or dental restoration,
- Patients receiving a general anesthetic (inhaled agent without nitrous oxide) with POV prophylaxis with two agents (ondansetron and dexamethasone)
- Post operative vomiting in PACU or second stage recovery requiring antiemetic rescue.
Key exclusion criteria (5 listed)
- Vomiting in the past 24 hours or antiemetics in previous 24 hours
- Allergy or sensitivity to ondansetron, dexamethasone, metoclopramide, or diphenhydramine
- Patients with diabetes
- Patients with seizures
- Patients receiving a benzodiazepine premedication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metaclopramide0.5 mg/kg for rescue after PONV | Drug | Metoclopramide |
| Ondansetron0.1 mg/kg (max 4 mg0 | Drug | Ondansetron |
| diphenhydramine0.25 mg/kg (max 25 mg) | Drug | Diphenhydramine |
| Salineequal volume (5 ml)as experimental rescue medications | Drug | Saline |
Primary outcome
Primary-Incidence of POV after rescue antiemetic in PACU, car ride home, day of surgery, and POD #1 and 2
Time frame: 48 hrs
3 secondary outcomes
Secondary - a. Discharge times
Time frame: 48 hrs
Adverse events (headaches, sedation, dystonic reaction, dry mouth)
Time frame: 48 hrs
POV risk factors. age, personal or family history of PONV, history of motion sickness, personal or family history of smoking
Time frame: 48 hrs
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franklyn P Cladis, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metaclopramide, Ondansetron and diphenhydramine in people with Post Operative Nausea and Vomiting and Rescue Emetic Therapy, run by Franklyn Cladis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary-Incidence of POV after rescue antiemetic in PACU, car ride home, day of surgery, and POD #1 and 2 (time frame: 48 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.