Post-tonsillectomy PainPhase 4NCT00472186
The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain
A Phase 4 study testing Lansoprazole in people with Post-tonsillectomy Pain and Post-tonsillectomy Activity, run by Boston Children's Hospital at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-tonsillectomy Pain, Post-tonsillectomy Activity, Post-tonsillectomy Hydration
- What is being tested?
- Lansoprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2008to Feb 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Surgery in addition to tonsillectomy/adenotonsillectomy (except for myringotomy)
- Cognitive/developmental disorders
- Inability to use a self-report pain scale
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Boston
Boston, Massachusetts, 02115
Childrens Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: The Effects of Gastro-esophageal Acid Suppression on Post-tonsillectomy Pain
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.
Read the 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:
- Take the study medication twice a day for 14 days.
- 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.
- 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.
- Being tested
- Lansoprazole, Placebo
- Keywords
- Tonsillectomy, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LansoprazoleDrug
Also called Prevacid
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.
PlaceboDrug
Placebo will also be administered based on weight.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Post-operative administration of Lansoprazole Receives: Drug: Lansoprazole |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome is the Number of Days to Become Free of Narcotic Pain Medication.
Measured: 2 weeks
Secondary outcomes (1)
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
- Study startJun 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Poor compliance with returning of logbooks by families. Two patients were enrolled. Only one returned the logbook and therefore not analyzed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-tonsillectomy PainStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manali Amin, Boston Children's Hospital
- Investigators
- Manali Amin, MD, Principal investigator, Children's Hosptial Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472186
- Sponsor's protocol ID
- 06-11-0513
- Status last verified
- Nov 2021
- First submitted
- 10 May 2007
- Last updated
- 6 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Gastro-esophageal Acid Suppression on Post-tonsillectomy Pain
- ClinicalTrials.gov ID
- NCT00472186
- Acronym / sponsor ID
- 06-11-0513
- Keywords
- Tonsillectomy, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor compliance with returning of logbooks by families. Two patients were enrolled. Only one returned the logbook and therefore not analyzed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jun 2008 (actual)
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 May 2007 (estimated)
- Results
- Posted 6 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Take the study medication twice a day for 14 days.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: LansoprazolePost-operative administration of Lansoprazole |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LansoprazoleAlso: PrevacidIf 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. | Drug | 1 |
| PlaceboPlacebo will also be administered based on weight. | Drug | 2 |
Primary outcome
The Primary Outcome is the Number of Days to Become Free of Narcotic Pain Medication.
Time frame: 2 weeks
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Post-tonsillectomy Pain
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium
Enrolling by invitationObservational study
Fasting Time and Post-tonsillectomy Pain
Tonsillar Disorder
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Sphenopalatine Ganglion Block for Pain Relief After Pediatric Adenotonsillectomy
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Not yet recruitingPhase 4
Topical Magnesium Sulfate Versus Peritonsillar Bupivacaine for Post-Tonsillectomy Pain Relief in Children
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manali Amin, MD principal investigator
Children's Hosptial Boston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lansoprazole in people with Post-tonsillectomy Pain and Post-tonsillectomy Activity, run by Boston Children's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Outcome is the Number of Days to Become Free of Narcotic Pain Medication. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.