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Poor compliance with returning of logbooks by families. Two patients were enrolled. Only one returned the logbook and therefore not analyzed
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This study was designed to determine whether post-operative pain following a tonsillectomy can be reduced by adding an antacid-like medication to the medications taken after surgery. It is hypothesized that even a small amount of stomach acid backing up and entering the mouth can increase post-tonsillectomy pain. Therefore, the use of an antacid-like medication should help to decrease pain and reduce the amount of narcotic medication required for pain control.
This study has been limited to children and adolescents ages 5-18 who are undergoing tonsillectomy for an indication of obstructive sleep disturbance (snoring, choking/gasping or pauses in breathing during sleep.)
Study participants will be randomized to two groups: study medication (Lansoprazole) or an inactive substance(placebo).
Participants will be asked to do all of the following:
Take the study medication twice a day for 14 days.
Keep a log book which will include:
Meet with a Research Assistant or Study Physician 14-21 days after the study to collect the log book and perform a post-operative examination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Post-operative administration of Lansoprazole |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole | Drug | If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered. |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome is the Number of Days to Become Free of Narcotic Pain Medication. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Secondary Outcomes Are the Number of Days to be Free of Pain, the Number of Days to Return to Normal Activity Levels and the Number of Days to Return to Normal Fluid Intake. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manali Amin, MD | Children's Hosptial Boston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States | ||
| Childrens Hospital Boston |
The study was terminated due to low recruitment, since only one participant returned logbooks with data there are concerns with confidentiality therefore no data is being reported.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1: Post-operative Administration of Lansoprazole | Lansoprazole: If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered. |
| FG001 | 2: Placebo | Placebo: Placebo will also be administered based on weight. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The study was terminated due to low recruitment, since only one participant returned logbooks with data there are concerns with confidentiality therefore no data is being reported.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1: Post-operative Administration of Lansoprazole | Lansoprazole: If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered. |
| BG001 | 2: Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Outcome is the Number of Days to Become Free of Narcotic Pain Medication. | The study was terminated due to low recruitment, since only one participant returned logbooks with data there are concerns with confidentiality therefore no data is being reported. | Posted | 2 weeks |
|
The study was terminated due to low recruitment, since only one participant returned logbooks with data there are concerns with confidentiality therefore no data is being reported.
The study was terminated due to low recruitment, since only one participant returned logbooks with data there are concerns with confidentiality therefore no data is being reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1: Post-operative Administration of Lansoprazole | Lansoprazole: If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manali Amin, MD | Dupage Chidlren's ENT & Allergy | 630-785-0367 | manali.amin@gmail.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | Placebo will also be administered based on weight. |
|
| Boston |
| Massachusetts |
| 02115 |
| United States |
Placebo: Placebo will also be administered based on weight. |
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | The Secondary Outcomes Are the Number of Days to be Free of Pain, the Number of Days to Return to Normal Activity Levels and the Number of Days to Return to Normal Fluid Intake. | The study was terminated due to low recruitment, since only one participant returned logbooks with data there are concerns with confidentiality therefore no data is being reported. | Posted | 2 weeks |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 2: Placebo | Placebo: Placebo will also be administered based on weight. | 0 | 0 | 0 | 0 |
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |