Anti-reflux Control to Decrease Post Tonsillectomy Pain
Study Details
Study Description
Brief 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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Omeprazole 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. |
Drug: Omeprazole
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.
Other Names:
|
| Placebo Comparator: Sugar pill 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. |
Drug: Omeprazole
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pain After Tonsillectomy [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Genesys Regional Medical Center | Grand Blanc | Michigan | United States | 48439 |
Sponsors and Collaborators
- Ascension Genesys Hospital
Investigators
- Principal Investigator: Carissa J Wentland, DO, Ascension Genesys Hospital
- Study Director: Kimberly Barber, PhD, Ascension Genesys Hospital
- Study Director: Candy Rainwater, Ascension Genesys Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GRMC 12 0020
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Omeprazole | Sugar Pill |
|---|---|---|
| Arm/Group Description | 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. Omeprazole: 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 | 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. Omeprazole: 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. |
| Period Title: Overall Study | ||
| STARTED | 3 | 3 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 3 | 3 |
Baseline Characteristics
| Arm/Group Title | Pre Treatment |
|---|---|
| Arm/Group Description | the study was terminated before patients received the medication The study did not progress to the point where the patients were randomized into different arms. |
| Overall Participants | 6 |
| Age (Count of Participants) | |
| <=18 years |
6
100%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
14
|
| Sex: Female, Male (Count of Participants) | |
| Female |
3
50%
|
| Male |
3
50%
|
| Region of Enrollment (participants) [Number] | |
| United States |
6
100%
|
Outcome Measures
| Title | Pain After Tonsillectomy |
|---|---|
| Description | 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. |
| Time Frame | 2 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The patients did not receive the intervention |
| Arm/Group Title | Pre Treatment |
|---|---|
| Arm/Group Description | |
| Measure Participants | 0 |
Adverse Events
| Time Frame | The data was not collected. | |
|---|---|---|
| Adverse Event Reporting Description | This data was not collected. | |
| Arm/Group Title | Pre Treatment | |
| Arm/Group Description | This data was not collected | |
All Cause Mortality |
||
| Pre Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Pre Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
| Pre Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Carissa Wentland DO |
|---|---|
| Organization | UH |
| Phone | 320-392-4737 |
| carissa.wentland@gmail.com |
- GRMC 12 0020