Laryngopharyngeal RefluxPhase 4NCT01777854
Anti-reflux Control to Decrease Post Tonsillectomy Pain
A Phase 4 study testing Omeprazole in people with Laryngopharyngeal Reflux and Throat Pain, run by Ascension Health at 1 site in United States.
Trial summary
The study aims to determine if treating pediatric patients (age 7-17) for four weeks with omeprazole prior to tonsillectomy will decrease post tonsillectomy pain. The hypothesis is that many patients have silent laryngopharyngeal reflux and by reducing the acid entrance into the oropharynx, patients will have less… Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Laryngopharyngeal Reflux, Throat Pain
- What is being tested?
- Omeprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jul 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 7-17 years old
- Weight >20 kg
- Scheduled to undergo a tonsillectomy (with or without adenoidectomy) in greater than four weeks.
- Health conditions (any of the following): Hypertrophic tonsils and adenoids, sleep disordered breathing, obstructive sleep apnea, chronic or recurrent tonsillitis, halitosis, dysphagia
- Must be able to swallow pills or tolerate taking the medication sprinkled on applesauce or other soft food.
Who cannot join
- Age <7
- Weight <20kg
- Patients declared by the parent not able to communicate pain level.
- Patients whose tonsillectomy is scheduled <4 weeks from the preoperative assessment (The patient would not have time to complete the preoperative treatment) (An exception to this exclusion criteria will be for the control group)
- Patients with a mental illness. This will be determined by the patient's physician or the physician overseeing the care of the patient.
- Unable to swallow pills or tolerate sprinkling the medication on soft food.
- Pregnant patients
- Any patients already taking Proton Pump Inhibitor
Trial locations and contacts
1 site in 1 country.
United States1 site
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
About this study
The study aims to determine if treating pediatric patients (age 7-17) for four weeks with omeprazole prior to tonsillectomy will decrease post tonsillectomy pain. The hypothesis is that many patients have silent laryngopharyngeal reflux and by reducing the acid entrance into the oropharynx, patients will have less post tonsillectomy pain due to decreased acid irritation of the surgical wound (tonsil fossas).
The study will be a prospective double blind randomized study. Participants will be invited to participate in the study by giving the study information at the preoperative assessment, when the decision is made to have a tonsillectomy performed. If the patient agrees to participate in the study, a written consent and child assent will be obtained and the patient will be randomly assigned to a treatment versus control group based on the randomly assigned participant number.
Read more
The treatment group will then be given a four week course of omeprazole to be taken for the four weeks prior to tonsillectomy. The patient will be given a post tonsillectomy assessment form. The form looks at postoperative pain (using a visual analog scale 1-10) as well as oral intake at postoperative day 0,1,3,5,7,10, and 14. The form will be turned in at the postoperative visit or mailed in.
The pain level and oral intake between the two groups to will be compared to determine if antireflux control helps decrease the postoperative pain after tonsillectomy.
Read the detailed description
The study aims to determine if treating pediatric patients (age 7-18) for four weeks with omeprazole prior to tonsillectomy will decrease post tonsillectomy pain. The hypothesis is that many patients have silent laryngopharyngeal reflux and by reducing the acid entrance into the oropharynx, patients will have less post tonsillectomy pain due to decreased acid irritation of the surgical wound (tonsil fossas).
The study will be a prospective double blind randomized study. Participants will be invited to participate in the study by giving the study information at the preoperative assessment, when the decision is made to have a tonsillectomy performed. If the patient agrees to participate in the study, a written consent and child assent will be obtained and the patient will be randomly assigned to a treatment versus control group based on the randomly assigned participant number.
The treatment group will then be given a four week course of omeprazole or placebo to be taken for the four weeks prior to tonsillectomy. The investigators will be blinded to the intervention. The medication will be kept in a locked drawer at the ENT Associates office. The patient will take the medication 20 mg orally once a day for 28 days prior to the procedure with day 28 being the day before the tonsillectomy. The patient will be provided with a calender that is marked with the start date of the medication. The patient is to document any missed doses on the calender. On the day of surgery, the patient will return the remainder of the medication in an opaque bag along with the calender and this will be given back to the research pharmacist to account for the medication.
The patient will be given a post tonsillectomy assessment form. The form looks at postoperative pain (using a visual analog scale 1-10) as well as oral intake at postoperative day 0,1,3,5,7,10, and 14. The form will be turned in at the postoperative visit (2 weeks after the surgery) or mailed in.
The pain level and oral intake between the two groups to will be compared to determine if antireflux control helps decrease the postoperative pain after tonsillectomy.
Other variables collected will be patient age, gender, method of surgery, pain medication prescribed, and indication for procedure. The data will be stored in a password protected computer files and the patient will only be identified by study number.
- Conditions
- Laryngopharyngeal Reflux, Throat Pain
- Being tested
- Omeprazole
- Medical subject headings
- Laryngopharyngeal Reflux, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Prilosec, Prilosec OTC
The principal investigator will be contacted and will work with the research pharmacist to obtain the omeprazole (20 mg PO daily for patients >20kg) and placebo. The placebo does not look like the omeprazole, however this will not be an issue because none of the subjects will have knowledge of how the medications look. The medication will be locked in the designated medication cabinet at each office. It will be prepackaged for a 28 day course. The patient will start the treatment 4 weeks prior to tonsillectomy and stop the day before surgery. The medication will be given to the patient once the consent and assent are signed. This will avoid an unnecessary office visit to improve patient compliance.
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole | Active comparator | Yes. Omeprazole (generic) will be used. Children >20 kg will be given 20 mg PO daily for 4 weeks prior to tonsillectomy. This is the normal standard pediatric dosing for reflux.
Omeprazole is authorized to treat reflux in children. The study focuses on laryngopharyngeal reflux that possibly contributes to post tonsillectomy pain. Receives: Drug: Omeprazole |
| Sugar pill | Placebo comparator | The placebo does not look like the omeprazole, however this will not be an issue because none of the subjects will have knowledge of how the medications look. Receives: Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain After Tonsillectomy
A questionnaire will be given to patients. Patients are asked to describe their pain and oral intake on post op days 0,1,3,5,7,10 and 14. This should take less than one minute per assessment day. At the end of the survey, they are asked to comment on any postoperative problems such as hemorrhage or dehydration. This should take less than 5 minutes. Parents will be asked to assist the child in completing the survey. They will be asked to turn in the form on the postoperative follow up visit (14-21 days after surgery) or mail it in to the principal investigator if the surgeon does not have a postoperative follow up visit. For these patients, an addressed and stamped envelope will be provided.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Lack of patient interest in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Laryngopharyngeal RefluxStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascension Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Carissa Wentland DO, Ascension Health
- Investigators
- Carissa J Wentland, DO, Principal investigator, Ascension HealthKimberly Barber, PhD, Study director, Ascension HealthCandy Rainwater, Study director, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777854
- Sponsor's protocol ID
- GRMC 12 0020
- Status last verified
- Sep 2018
- First submitted
- 25 Jan 2013
- Last updated
- 24 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-reflux Control to Decrease Post Tonsillectomy Pain
- ClinicalTrials.gov ID
- NCT01777854
- Acronym / sponsor ID
- GRMC 12 0020
- Conditions
- Laryngopharyngeal Reflux, Throat Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patient interest in the study.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Ascension HealthIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Posted 25 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to determine if treating pediatric patients (age 7-17) for four weeks with omeprazole prior to tonsillectomy will decrease post tonsillectomy pain. The hypothesis is that many patients have silent laryngopharyngeal reflux and by reducing the acid entrance into the oropharynx, patients will have less post tonsillectomy pain due to decreased acid irritation of the surgical wound (tonsil fossas).
The study will be a prospective double blind randomized study. Participants will be invited to participate in the study by giving the study information at the preoperative assessment, when the decision is made to have a tonsillectomy performed. If the patient agrees to participate in the study, a written consent and child assent will be obtained and the patient will be randomly assigned to a treatment versus control group based on the randomly assigned participant number.
The treatment group will then be given a four week course of omeprazole to be taken for the four weeks prior to tonsillectomy. The patient will be given a post tonsillectomy assessment form. The form looks at postoperative pain (using a visual analog scale 1-10) as well as oral intake at postoperative day 0,1,3,5,7,10, and 14. The form will be turned in at the postoperative visit or mailed in.
The pain level and oral intake between the two groups to will be compared to determine if antireflux control helps decrease the postoperative pain after tonsillectomy.
Detailed description
The study aims to determine if treating pediatric patients (age 7-18) for four weeks with omeprazole prior to tonsillectomy will decrease post tonsillectomy pain. The hypothesis is that many patients have silent laryngopharyngeal reflux and by reducing the acid entrance into the oropharynx, patients will have less post tonsillectomy pain due to decreased acid irritation of the surgical wound (tonsil fossas).
The study will be a prospective double blind randomized study. Participants will be invited to participate in the study by giving the study information at the preoperative assessment, when the decision is made to have a tonsillectomy performed. If the patient agrees to participate in the study, a written consent and child assent will be obtained and the patient will be randomly assigned to a treatment versus control group based on the randomly assigned participant number.
The treatment group will then be given a four week course of omeprazole or placebo to be taken for the four weeks prior to tonsillectomy. The investigators will be blinded to the intervention. The medication will be kept in a locked drawer at the ENT Associates office. The patient will take the medication 20 mg orally once a day for 28 days prior to the procedure with day 28 being the day before the tonsillectomy. The patient will be provided with a calender that is marked with the start date of the medication. The patient is to document any missed doses on the calender. On the day of surgery, the patient will return the remainder of the medication in an opaque bag along with the calender and this will be given back to the research pharmacist to account for the medication.
The patient will be given a post tonsillectomy assessment form. The form looks at postoperative pain (using a visual analog scale 1-10) as well as oral intake at postoperative day 0,1,3,5,7,10, and 14. The form will be turned in at the postoperative visit (2 weeks after the surgery) or mailed in.
The pain level and oral intake between the two groups to will be compared to determine if antireflux control helps decrease the postoperative pain after tonsillectomy.
Other variables collected will be patient age, gender, method of surgery, pain medication prescribed, and indication for procedure. The data will be stored in a password protected computer files and the patient will only be identified by study number.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omeprazole | Active comparator | Drug: OmeprazoleYes. Omeprazole (generic) will be used. Children >20 kg will be given 20 mg PO daily for 4 weeks prior to tonsillectomy. This is the normal standard pediatric dosing for reflux. Omeprazole is authorized to treat reflux in children. The study focuses on laryngopharyngeal reflux that possibly contributes to post tonsillectomy pain. |
| Sugar pill | Placebo comparator | Drug: OmeprazoleThe placebo does not look like the omeprazole, however this will not be an issue because none of the subjects will have knowledge of how the medications look. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 7-17 years old
- Weight >20 kg
- Scheduled to undergo a tonsillectomy (with or without adenoidectomy) in greater than four weeks.
- Health conditions (any of the following): Hypertrophic tonsils and adenoids, sleep disordered breathing, obstructive sleep apnea, chronic or recurrent tonsillitis, halitosis, dysphagia
- Must be able to swallow pills or tolerate taking the medication sprinkled on applesauce or other soft food.
Key exclusion criteria (8 listed)
- Age <7
- Weight <20kg
- Patients declared by the parent not able to communicate pain level.
- Patients whose tonsillectomy is scheduled <4 weeks from the preoperative assessment (The patient would not have time to complete the preoperative treatment) (An exception to this exclusion criteria will be for the control group)
- Patients with a mental illness. This will be determined by the patient's physician or the physician overseeing the care of the patient.
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 |
|---|---|---|
| OmeprazoleAlso: Prilosec, Prilosec OTCThe principal investigator will be contacted and will work with the research pharmacist to obtain the omeprazole (20 mg PO daily for patients >20kg) and placebo. The placebo does not look like the omeprazole, however this will not be an issue because none of the subjects will have knowledge of how the medications look. The medication will be locked in the designated medication cabinet at each office. It will be prepackaged for a 28 day course. The patient will start the treatment 4 weeks prior to tonsillectomy and stop the day before surgery. The medication will be given to the patient once the consent and assent are signed. This will avoid an unnecessary office visit to improve patient compliance. | Drug | Omeprazole, Sugar pill |
Primary outcome
Pain After Tonsillectomy
Time frame: 2 weeks
A questionnaire will be given to patients. Patients are asked to describe their pain and oral intake on post op days 0,1,3,5,7,10 and 14. This should take less than one minute per assessment day. At the end of the survey, they are asked to comment on any postoperative problems such as hemorrhage or dehydration. This should take less than 5 minutes. Parents will be asked to assist the child in completing the survey. They will be asked to turn in the form on the postoperative follow up visit (14-21 days after surgery) or mail it in to the principal investigator if the surgeon does not have a postoperative follow up visit. For these patients, an addressed and stamped envelope will be provided.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Laryngopharyngeal Reflux
RecruitingPhase 2
Fosamprenavir for Laryngopharyngeal Upper Airway Tissue Treatment and Enzyme Reduction
Laryngopharyngeal Reflux
Enrolling by invitationObservational study
The Johns Hopkins Heartburn Center Registry
Gastroesophageal Reflux Disease, Barrett Esophagus
Enrolling by invitationObservational study
Effect of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) on Gastric Emptying
Gastric Emptying, Glucagon-Like Peptide-1 Receptor Agonists
Recruiting
New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease (The RELIEF Trial)
GERD (Gastroesophageal Reflux Disease), NERD
Not yet recruitingPhase 4
Comparative Effectiveness of Alginate, Magaldrate, Sucralfate, Proton Pump Inhibitors, and Diet in Laryngopharyngeal Reflux Disease
Laryngopharyngeal Reflux Disease
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.
Carissa J Wentland, DO principal investigator
Ascension Health
Kimberly Barber, PhD study director
Ascension Health
Candy Rainwater study director
Ascension Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omeprazole in people with Laryngopharyngeal Reflux and Throat Pain, run by Ascension Health 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 24 Oct 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain After Tonsillectomy (time frame: 2 weeks). 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 24 Oct 2018.