TonsillectomyPhase 3NCT01332253
Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy
A Phase 3 study testing Intravenous ibuprofen and Normal Saline in people with Tonsillectomy, run by Cumberland Pharmaceuticals at 6 sites in United States.
Trial summary
The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will significantly reduce post-operative fentanyl use compared to placebo. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Tonsillectomy
- What is being tested?
- Intravenous ibuprofen and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2011to Aug 2012
- Phase
- Phase 3
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Patients between 6 and 17 years of age scheduled to undergo tonsillectomy.
Who cannot join
- Have inadequate intravenous access
- Patients with significant cognitive impairment
- Active, clinically significant asthma
- History of allergy or hypersensitivity to any component of intravenous ibuprofen, NSAIDs, aspirin (or related products), cyclooxygenase-2 inhibitors, or fentanyl.
- Have a history of congenital bleeding diathesis (e.g. hemophilia) or any active clinically significant bleeding
- Any child with obstructive sleep apnea, defined as an Apnea-Hypopnea Index of greater than or equal to 5.0
Show all 10Show fewer
- Have taken investigational drugs within 30 days before clinical trial material administration.
- Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions. Surrogates will be needed for most patients.
- Refusal to provide written authorization for use and disclosure of protected health information.
- Be otherwise unsuitable for the study, in the opinion of the Investigator.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Southeastern Clinical Research Associates
Charlotte, North Carolina, 28210
Comprehensive Pain Specialists
Hendersonville, Tennessee, 37075
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, 77030
Advanced ENT & Allergy
Louisville, Kentucky, 40207
University Hospital, University of Medicine and Dentistry NJ
Newark, New Jersey, 07101
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Trial of the Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy
The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will significantly reduce post-operative fentanyl use compared to placebo.
- Conditions
- Tonsillectomy
- Being tested
- Intravenous ibuprofen, Normal Saline
- Keywords
- Tonsillectomy, Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ibuprofenDrug
Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
Normal SalineOther
Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Ibuprofen | Experimental | Not described Receives: Drug: Intravenous ibuprofen |
| Normal Saline | Placebo comparator | Not described Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge.
To evaluate the primary objective of reduced fentanyl use in the post-operative period, the number of fentanyl doses (0.5 mcg/kg IV) administered in the post-operative period prior to discharge will be measured.
Measured: 4 hours
Secondary outcomes (10)
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 30 Minutes Post-procedure.
The patient's self-reported pain at 30 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain.
Measured: 30 minutes post-procedure
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 60 Minutes Post-procedure.
To evaluate the secondary objective of pain, the patient's self-reported pain at 60 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain.
Measured: 60 minutes post-procedure
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 90 Minutes Post-procedure.
- evaluate the secondary objective of pain, the patient's self-reported pain at 90 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain.
Measured: 90 minutes post-procedure
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 120 Minutes Post-procedure.
To evaluate the secondary objective of pain, the patient's self-reported pain at 120 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain.
Measured: 120 minutes post-procedure
Time to Discharge Post Procedure.
To evaluate the secondary objective of pain, the time to participant discharge will be measured.
Measured: Discharge
Time to Swallow Post Procedure.
Swallowing will be assessed every 15 minutes following arrival to the recovery room; the time to first swallow will be recorded.
Measured: every 15 minutes until able to swallow
Parent Satisfaction With Regards to Pain Management Post Procedure.
To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to pain management. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 1 asked "How satisfied were you with your child's pain management at the time of discharge?"
Measured: Discharge
Parent Satisfaction With Regards to Nausea Management Post Procedure.
To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to nausea management. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 2 asked "How satisfied were you with your child's nausea management during the study?"
Measured: Discharge
Parental Satisfaction With Vomiting Control in the Post-Operative Period.
To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to vomiting control. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 3 asked "How satisfied were you with your child's vomiting management during the study?"
Measured: Discharge
Blood Loss During Surgery
Amount of Blood Lost During Surgery in milliliters
Measured: End of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionAug 2012
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 TonsillectomyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Art P Wheeler, MD, Study director, Cumberland Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332253
- Sponsor's protocol ID
- CPI-CL-014
- Status last verified
- Sep 2016
- First submitted
- 7 Apr 2011
- Last updated
- 3 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Trial of the Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy
- ClinicalTrials.gov ID
- NCT01332253
- Acronym / sponsor ID
- CPI-CL-014
- Conditions
- Tonsillectomy
- Keywords
- Tonsillectomy, Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 Apr 2011 (estimated)
- Results
- Posted 3 Nov 2016
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 a single, pre-operative dose of intravenous ibuprofen will significantly reduce post-operative fentanyl use compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Ibuprofen | Experimental | Drug: Intravenous ibuprofen |
| Normal Saline | Placebo comparator | Other: Normal Saline |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Patients between 6 and 17 years of age scheduled to undergo tonsillectomy.
Key exclusion criteria (10 listed)
- Have inadequate intravenous access
- Patients with significant cognitive impairment
- Active, clinically significant asthma
- History of allergy or hypersensitivity to any component of intravenous ibuprofen, NSAIDs, aspirin (or related products), cyclooxygenase-2 inhibitors, or fentanyl.
- Have a history of congenital bleeding diathesis (e.g. hemophilia) or any active clinically significant bleeding
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 |
|---|---|---|
| Intravenous ibuprofenParticipants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia. | Drug | Intravenous Ibuprofen |
| Normal SalineParticipants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia. | Other | Normal Saline |
Primary outcome
Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge.
Time frame: 4 hours
To evaluate the primary objective of reduced fentanyl use in the post-operative period, the number of fentanyl doses (0.5 mcg/kg IV) administered in the post-operative period prior to discharge will be measured.
10 secondary outcomes
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 30 Minutes Post-procedure.
Time frame: 30 minutes post-procedure
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 60 Minutes Post-procedure.
Time frame: 60 minutes post-procedure
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 90 Minutes Post-procedure.
Time frame: 90 minutes post-procedure
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 120 Minutes Post-procedure.
Time frame: 120 minutes post-procedure
Time to Discharge Post Procedure.
Time frame: Discharge
Time to Swallow Post Procedure.
Time frame: every 15 minutes until able to swallow
Parent Satisfaction With Regards to Pain Management Post Procedure.
Time frame: Discharge
Parent Satisfaction With Regards to Nausea Management Post Procedure.
Time frame: Discharge
Parental Satisfaction With Vomiting Control in the Post-Operative Period.
Time frame: Discharge
Blood Loss During Surgery
Time frame: End of Surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Art P Wheeler, MD study director
Cumberland Pharmaceuticals
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous ibuprofen and Normal Saline in people with Tonsillectomy, run by Cumberland Pharmaceuticals at 6 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 10 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 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 3 Nov 2016). 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?
Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge. (time frame: 4 hours). 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 3 Nov 2016.