Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472186
Status:
TERMINATED
Last Update Posted:
2021-12-06
First Post:
2007-05-10
Brief Title:
The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
The Effects of Gastro-esophageal Acid Suppression on Post-tonsillectomy Pain
Status:
TERMINATED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor compliance with returning of logbooks by families Two patients were enrolled Only one returned the logbook and therefore not analyzed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 chokinggasping or pauses in breathing during sleep
Study participants will be randomized to two groups study medication Lansoprazole or an inactive substanceplacebo
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 childs activity level daily for 14 days
Collect your childs 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
Study participants will be randomized to two groups study medication Lansoprazole or an inactive substanceplacebo
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 childs activity level daily for 14 days
Collect your childs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None