TonsillitisPhase 2NCT00583453
Celecoxib as a Post-tonsillectomy Pain Medication
A Phase 2 study testing Celecoxib in people with Tonsillitis, run by University of Iowa at 1 site in United States.
Trial summary
The hypothesis is that celecoxib effectively reduces pain after a tonsillectomy and reduces post-operative narcotic use. To test this hypothesis, the study is placebo controlled (sugar pill). Half of the participants will receive a sugar pill, half will not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tonsillitis
- What is being tested?
- Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to May 2016
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 18 years
- Indication for tonsillectomy (patients undergoing a tonsillectomy as a portion of additional surgical procedures will not be included)
- Have the ability to understand and the willingness to sign a written informed consent document
Who cannot join
- History of bleeding disorders
- History of liver or kidney dysfunction
- History of allergy to sulfa containing medications
- History of lactose intolerance
- History of asthma, urticaria, or allergic-type reactions to aspirin or NSAIDs
- Women who are currently pregnant, nursing, or trying to conceive
Show all 11Show fewer
- History of allergy or intolerance to acetaminophen or hydrocodone
- History of allergy to any COX-2 inhibitor, including celecoxib or rofecoxib.
- PT, PTT, hemoglobin, or hematocrit values that are outside of institutional limits.
- History of cardiovascular disease
- Patients currently taking celecoxib
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
About this study
Official title: Perioperative Use of Celecoxib to Improve Pain Control in Patients Undergoing Tonsillectomy: a Randomized, Double Blind, Placebo-controlled Trial
The hypothesis is that celecoxib effectively reduces pain after a tonsillectomy and reduces post-operative narcotic use.
To test this hypothesis, the study is placebo controlled (sugar pill). Half of the participants will receive a sugar pill, half will not.
All participants will receive the standard post-operative pain medications.
We ask participants to log the amount of medications they use daily, and the amount of pain they have each day. It is hoped that celecoxib will reduce the amount of post-operative pain medication needed.
Read the detailed description
Post-tonsillectomy pain is typically controlled through narcotic medications, such as Lortab elixir. Despite its standard use, this pain control is typically not as effective as a non-steroidal anti-inflammatory medication (NSAID). The problem with using NSAIDs for post-tonsillectomy operative pain is the significant increased risk of rebleeding.
Celecoxib is an NSAID that is a COX-2 inhibitor; the drug is designed to act as an NSAID without the increased risk of rebleeding or hemorrhage.
This study is a double blind, randomized study; neither the study participant or the study investigator knows if the participant is receiving celecoxib or a placebo (sugar pill). The blinded list is maintained by the research pharmacists and can be unblinded when needed (such as in an emergency).
Participants begin taking the study medication the night before surgery and continue through 10 days post-operative. Participants are asked to complete a journal that catalogs the amount of standard post-operative medications taken, the amount of pain experienced, and any other comments.
Participants are contacted by phone at 5 and 10 days post-op.
Study participation ends at the standard 3-week post-operative check-up.
- Conditions
- Tonsillitis
- Being tested
- Celecoxib, Placebo
- Keywords
- Tonsillectomy, Analgesia, Pain measurement, Celecoxib
- Medical subject headings
- Tonsillitis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celebrex
Celecoxib 200 mg capsule
- capsule the night before surgery
- capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
PlaceboDrug
Placebo capsule
- capsule the night before surgery
- capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Celecoxib 200 mg tablets Receives: Drug: Celecoxib |
| B | Placebo comparator | Placebo with same dosing schedule as the active comparator arm Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Pain Score
Pain score as reported by participant, measured on a 10 point scale, where 0 = none and 10 = unbearable, collected once daily.
Measured: day of procedure through post-operative day 10
Secondary outcomes (4)
Self-reported Activity Level
Activity level, reported by participant utilizing a 10-point ordinal scale (0 = no activity, 10 = return to normal activities). Activity level was measured was collected once daily.
Measured: From operative day through 10 days post-operative
Acetaminophen Equivalent Use
Participant reported acetaminophen use and its equivalent. Medication use was collected from reported participant journals.
Measured: From operative day through 10 days post-operative
Incidence of Post-operative Hemorrhage
The incidence of post-operative hemorrhage, defined as post-operative bleeding requiring medical intervention or hospitalization during the 10 day post-operative follow-up period.
Measured: From operative day through 10 days post-operative
Total Morphine Equivalent
Participant reported mophine equivalent use
Measured: From operative day through 10 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2013
- Study completionMay 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TonsillitisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Douglas J Van Daele, University of Iowa
- Investigators
- Douglas VanDaele, MD, Principal investigator, Department of Otolaryngology-Head & Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583453
- Sponsor's protocol ID
- 200703765
- Status last verified
- Feb 2017
- First submitted
- 20 Dec 2007
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be uploaded through clinicaltrials.gov data tables
Publications
Van Daele DJ, Bodeker KL, Trask DK. Celecoxib Versus Placebo in Tonsillectomy: A Prospective, Randomized, Double-Blind Placebo-Controlled Trial. Ann Otol Rhinol Laryngol. 2016 Oct;125(10):785-800. doi: 10.1177/0003489416654707. Epub 2016 Jun 29.
PubMed 27357971
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Use of Celecoxib to Improve Pain Control in Patients Undergoing Tonsillectomy: a Randomized, Double Blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00583453
- Acronym / sponsor ID
- 200703765
- Conditions
- Tonsillitis
- Keywords
- Tonsillectomy, Analgesia, Pain measurement, Celecoxib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 31 Dec 2007 (estimated)
- Results
- Posted 29 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis is that celecoxib effectively reduces pain after a tonsillectomy and reduces post-operative narcotic use.
To test this hypothesis, the study is placebo controlled (sugar pill). Half of the participants will receive a sugar pill, half will not.
All participants will receive the standard post-operative pain medications.
We ask participants to log the amount of medications they use daily, and the amount of pain they have each day. It is hoped that celecoxib will reduce the amount of post-operative pain medication needed.
Detailed description
Post-tonsillectomy pain is typically controlled through narcotic medications, such as Lortab elixir. Despite its standard use, this pain control is typically not as effective as a non-steroidal anti-inflammatory medication (NSAID). The problem with using NSAIDs for post-tonsillectomy operative pain is the significant increased risk of rebleeding.
Celecoxib is an NSAID that is a COX-2 inhibitor; the drug is designed to act as an NSAID without the increased risk of rebleeding or hemorrhage.
This study is a double blind, randomized study; neither the study participant or the study investigator knows if the participant is receiving celecoxib or a placebo (sugar pill). The blinded list is maintained by the research pharmacists and can be unblinded when needed (such as in an emergency).
Participants begin taking the study medication the night before surgery and continue through 10 days post-operative. Participants are asked to complete a journal that catalogs the amount of standard post-operative medications taken, the amount of pain experienced, and any other comments.
Participants are contacted by phone at 5 and 10 days post-op.
Study participation ends at the standard 3-week post-operative check-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: CelecoxibCelecoxib 200 mg tablets |
| B | Placebo comparator | Drug: PlaceboPlacebo with same dosing schedule as the active comparator arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age at least 18 years
- Indication for tonsillectomy (patients undergoing a tonsillectomy as a portion of additional surgical procedures will not be included)
- Have the ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (11 listed)
- History of bleeding disorders
- History of liver or kidney dysfunction
- History of allergy to sulfa containing medications
- History of lactose intolerance
- History of asthma, urticaria, or allergic-type reactions to aspirin or NSAIDs
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 |
|---|---|---|
| CelecoxibAlso: CelebrexCelecoxib 200 mg capsule 1. capsule the night before surgery 2. capsules the morning of surgery 1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery | Drug | A |
| PlaceboPlacebo capsule 1. capsule the night before surgery 2. capsules the morning of surgery 1 capsule the night of surgery 1 capsule twice daily for 10 days immediately after the surgery | Drug | B |
Primary outcome
Self-reported Pain Score
Time frame: day of procedure through post-operative day 10
Pain score as reported by participant, measured on a 10 point scale, where 0 = none and 10 = unbearable, collected once daily.
4 secondary outcomes
Self-reported Activity Level
Time frame: From operative day through 10 days post-operative
Acetaminophen Equivalent Use
Time frame: From operative day through 10 days post-operative
Incidence of Post-operative Hemorrhage
Time frame: From operative day through 10 days post-operative
Total Morphine Equivalent
Time frame: From operative day through 10 days post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27357971Van Daele DJ, Bodeker KL, Trask DK. Celecoxib Versus Placebo in Tonsillectomy: A Prospective, Randomized, Double-Blind Placebo-Controlled Trial. Ann Otol Rhinol Laryngol. 2016 Oct;125(10):785-800. doi: 10.1177/0003489416654707. Epub 2016 Jun 29.
- Individual participant dataSharing planned: Yes. Data will be uploaded through clinicaltrials.gov data tables
Related trials for Tonsillitis
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Active, not recruiting
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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.
Douglas VanDaele, MD principal investigator
Department of Otolaryngology-Head & Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib in people with Tonsillitis, run by University of Iowa at 1 site 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 29 Mar 2017). 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?
Self-reported Pain Score (time frame: day of procedure through post-operative day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00583453, which also lists 1 linked publication.
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 29 Mar 2017; AzTrials last refreshed its copy on 30 Oct 2026.