Post-tonsillectomy Activity, Post-tonsillectomy Hydration, Post-tonsillectomy Pain
Conditions
Keywords
Tonsillectomy, Pain
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, 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.
Interventions
DRUGLansoprazole
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.
DRUGPlacebo
Placebo will also be administered based on weight.
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* All healthy children ages 5-18 years scheduled for tonsillectomy and /or adenotonsillectomy for sleep disturbance secondary to airway obstruction at Children's Hospital Boston
Exclusion criteria
* Patients on any medications other than the study drug (Lansoprazole or placebo), Amoxicillin®, and acetaminophen with or without codeine * An underlying medical condition which would necessitate an alteration in the anesthetic regimen * Patients allergic to any of the medications in the protocol * History of chronic tonsillitis * History of chronic pain conditions * History of active gastro-esophageal reflux disease * Surgery in addition to tonsillectomy/adenotonsillectomy (except for myringotomy) * Cognitive/developmental disorders * Inability to use a self-report pain scale
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Outcome is the Number of Days to Become Free of Narcotic Pain Medication. | 2 weeks |
Secondary
| Measure | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 2: Placebo Placebo: Placebo will also be administered based on weight. | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study was terminated due to poor compliance with returning logbooks by families. | 1 | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
The Primary Outcome is the Number of Days to Become Free of Narcotic Pain Medication.
Time frame: 2 weeks
Population: 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.
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.
Time frame: 2 weeks
Population: 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.