Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT00472186 |
| Other study ID # |
06-11-0513 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
June 2008 |
| Est. completion date |
February 2011 |
Study information
| Verified date |
November 2021 |
| Source |
Boston Children's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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:
1. Take the study medication twice a day for 14 days.
2. Keep a log book which will include:
- Record the medications and amount of each medication taken each day for 14 days.
This includes pain medication and the study drug.
- Record your child's activity level daily for 14 days.
- Collect your child's urine one time daily and test it using special medicated
strips to monitor their daily liquid intake for 14 days.
3. 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.
