Pain, PostoperativePhase 3NCT04551196
Management of Post-Tonsillectomy Pain in Pediatric Patients
A Phase 3 study testing Alternating Acetaminophen and Ibuprofen and Combined Acetaminophen and Ibuprofen in people with Pain, Postoperative and Tonsillar Hypertrophy, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Pain, Postoperative, Tonsillar Hypertrophy, Tonsillitis
- What is being tested?
- Alternating Acetaminophen and Ibuprofen and Combined Acetaminophen and Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to 10 Nov 2022
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 4 to 17 years of age at time of enrollment
- Undergoing tonsillectomy with or without adenoidectomy
- Able to provide informed consent from parent or legal guardian
- Able to provide assent if subject is a minor of appropriate age
Who cannot join
- Allergy to acetaminophen or ibuprofen
- Inability for study participant to cooperate with pain assessments
- Known pregnancy
- Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: Effectiveness of a Combined Acetaminophen and Ibuprofen Regimen for Management of Post-Tonsillectomy Pain in Pediatric Patients
Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. 100 children undergoing tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed every 3 hours.
- Conditions
- Pain, Postoperative, Tonsillar Hypertrophy, Tonsillitis
- Being tested
- Alternating Acetaminophen and Ibuprofen, Combined Acetaminophen and Ibuprofen
- Medical subject headings
- Pain, Postoperative, Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternating Acetaminophen and IbuprofenDrug
Also called Alternating regimen
Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
Combined Acetaminophen and IbuprofenDrug
Also called Combined regimen
Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Alternating Regimen | Active comparator | A regimen of acetaminophen and ibuprofen alternating doses every 3 hours. Receives: Drug: Alternating Acetaminophen and Ibuprofen |
| Combined Regimen | Active comparator | A regimen of acetaminophen and ibuprofen dosed together every 6 hours. Receives: Drug: Combined Acetaminophen and Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3
The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 from POD 1 through POD 3 compared between the combined and the alternating medication regimens.
The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.
Measured: up to 3 days following consent
Secondary outcomes (8)
Number of Participants With FLACC Pain Scores ≥7 on Each Individual POD 1, 3, and 7
The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 on each individual POD 1, 3, and 7 compared between the combined and the alternating medication regimens.
The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.
Measured: 3 separate individual days, will be completed days after the surgery
Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 7
The proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7 compared between the combined and the alternating medication regimens.
The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.
Measured: up to 7 days following consent
Number of Participants With Faces Pain Scores ≥8 on POD 1, 3, and 7
The proportion of Faces pain scores ≥8 on POD 1, 3, and 7 compared between the combined and the alternating medication regimens.
The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
Measured: 3 separate individual days, will be completed days after the surgery
Number of Participants With Cumulative Faces Pain Scores ≥8 From POD 1 Through POD 7
The proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 7 compared between the combined and the alternating medication regimens.
The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
Measured: up to 7 days following consent
Number of Participants With Rescue Medication Usage Through POD 3
The proportion of rescue medication usage from POD 1 through POD 3 compared between the combined and the alternating medication regimens.
Measured: up to 3 days following consent
Number of Participants With Rescue Medication Usage Through POD 7
The proportion of rescue medication usage from POD 1 through POD 7 compared between the combined and the alternating medication regimens.
Measured: up to 7 days following consent
Proportion of Subjects That Adhere to the Assigned Medication Regimen
Proportion of subjects that adhere to the assigned medication regimen compared between the combined and the alternating medication regimens as determined by the medication log that the participants return at the end of the study.
Measured: up to 3 days following consent
Adverse Events
Incidence of adverse events
Measured: up to 7 days following consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start28 Sep 2020
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
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 (15)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized, open-label, non-inferiority treatment pilot study
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551196
- Sponsor's protocol ID
- 202002118
- Status last verified
- Jul 2024
- First submitted
- 9 Sep 2020
- Last updated
- 11 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update). Otolaryngol Head Neck Surg. 2019 Feb;160(1_suppl):S1-S42. doi: 10.1177/0194599818801757.
PubMed 30798778Ingram DG, Friedman NR. Toward Adenotonsillectomy in Children: A Review for the General Pediatrician. JAMA Pediatr. 2015 Dec;169(12):1155-61. doi: 10.1001/jamapediatrics.2015.2016.
PubMed 26436644National Prospective Tonsillectomy Audit Final Report. Royal College of Surgeons https://www.rcseng.ac.uk/library-and-publications/rcs-publications/docs/tonsillectomy-audit/
Alvarez Palacios I, Gonzalez-Orus Alvarez-Morujo R, Alonso Martinez C, Ayala Mejias A, Arenas Britez O. Postoperative Pain in Adult Tonsillectomy: Is There Any Difference Between the Technique? Indian J Otolaryngol Head Neck Surg. 2017 Jun;69(2):187-193. doi: 10.1007/s12070-017-1058-9. Epub 2017 Jan 16.
PubMed 28607888Lauder G, Emmott A. Confronting the challenges of effective pain management in children following tonsillectomy. Int J Pediatr Otorhinolaryngol. 2014 Nov;78(11):1813-27. doi: 10.1016/j.ijporl.2014.08.011. Epub 2014 Aug 27.
PubMed 25241379Tobias JD, Green TP, Cote CJ; SECTION ON ANESTHESIOLOGY AND PAIN MEDICINE; COMMITTEE ON DRUGS. Codeine: Time to Say "No". Pediatrics. 2016 Oct;138(4):e20162396. doi: 10.1542/peds.2016-2396. Epub 2016 Sep 19.
PubMed 27647717Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906.
PubMed 25624387Ismail Zaidan & Amanda Lent. Post-Tonsillectomy Pain in Children: The Postcodeine Era. US Pharm. 41, 31-34 (2016).
D'Souza JN, Schmidt RJ, Xie L, Adelman JP, Nardone HC. Postoperative nonsteroidal anti-inflammatory drugs and risk of bleeding in pediatric intracapsular tonsillectomy. Int J Pediatr Otorhinolaryngol. 2015 Sep;79(9):1472-6. doi: 10.1016/j.ijporl.2015.05.042. Epub 2015 Jul 2.
PubMed 26164211Lewis SR, Nicholson A, Cardwell ME, Siviter G, Smith AF. Nonsteroidal anti-inflammatory drugs and perioperative bleeding in paediatric tonsillectomy. Cochrane Database Syst Rev. 2013 Jul 18;2013(7):CD003591. doi: 10.1002/14651858.CD003591.pub3.
PubMed 23881651Merry AF, Gibbs RD, Edwards J, Ting GS, Frampton C, Davies E, Anderson BJ. Combined acetaminophen and ibuprofen for pain relief after oral surgery in adults: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):80-8. doi: 10.1093/bja/aep338.
PubMed 20007794Miranda HF, Puig MM, Prieto JC, Pinardi G. Synergism between paracetamol and nonsteroidal anti-inflammatory drugs in experimental acute pain. Pain. 2006 Mar;121(1-2):22-8. doi: 10.1016/j.pain.2005.11.012. Epub 2006 Feb 9.
PubMed 16480830Gardiner P, Dvorkin L. Promoting medication adherence in children. Am Fam Physician. 2006 Sep 1;74(5):793-8.
PubMed 16970023Haynes RB, McKibbon KA, Kanani R. Systematic review of randomised trials of interventions to assist patients to follow prescriptions for medications. Lancet. 1996 Aug 10;348(9024):383-6. doi: 10.1016/s0140-6736(96)01073-2.
PubMed 8709739Uitti JM, Salantera S, Laine MK, Tahtinen PA, Ruohola A. Adaptation of pain scales for parent observation: are pain scales and symptoms useful in detecting pain of young children with the suspicion of acute otitis media? BMC Pediatr. 2018 Dec 20;18(1):392. doi: 10.1186/s12887-018-1361-y.
PubMed 30572868
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Combined Acetaminophen and Ibuprofen Regimen for Management of Post-Tonsillectomy Pain in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04551196
- Acronym / sponsor ID
- 202002118
- Conditions
- Pain, Postoperative, Tonsillar Hypertrophy, Tonsillitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Posted 11 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. 100 children undergoing tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed every 3 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, randomized, open-label, non-inferiority treatment pilot study
| Arm | Type | Receives |
|---|---|---|
| Alternating Regimen | Active comparator | Drug: Alternating Acetaminophen and IbuprofenA regimen of acetaminophen and ibuprofen alternating doses every 3 hours. |
| Combined Regimen | Active comparator | Drug: Combined Acetaminophen and IbuprofenA regimen of acetaminophen and ibuprofen dosed together every 6 hours. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 4 to 17 years of age at time of enrollment
- Undergoing tonsillectomy with or without adenoidectomy
- Able to provide informed consent from parent or legal guardian
- Able to provide assent if subject is a minor of appropriate age
Key exclusion criteria (4 listed)
- Allergy to acetaminophen or ibuprofen
- Inability for study participant to cooperate with pain assessments
- Known pregnancy
- Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
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 |
|---|---|---|
| Alternating Acetaminophen and IbuprofenAlso: Alternating regimenSubjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours. | Drug | Alternating Regimen |
| Combined Acetaminophen and IbuprofenAlso: Combined regimenSubjects will take their post-operative acetaminophen and ibuprofen together every 6 hours. | Drug | Combined Regimen |
Primary outcome
Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3
Time frame: up to 3 days following consent
The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 from POD 1 through POD 3 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.
8 secondary outcomes
Number of Participants With FLACC Pain Scores ≥7 on Each Individual POD 1, 3, and 7
Time frame: 3 separate individual days, will be completed days after the surgery
Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 7
Time frame: up to 7 days following consent
Number of Participants With Faces Pain Scores ≥8 on POD 1, 3, and 7
Time frame: 3 separate individual days, will be completed days after the surgery
Number of Participants With Cumulative Faces Pain Scores ≥8 From POD 1 Through POD 7
Time frame: up to 7 days following consent
Number of Participants With Rescue Medication Usage Through POD 3
Time frame: up to 3 days following consent
Number of Participants With Rescue Medication Usage Through POD 7
Time frame: up to 7 days following consent
Proportion of Subjects That Adhere to the Assigned Medication Regimen
Time frame: up to 3 days following consent
Adverse Events
Time frame: up to 7 days following consent
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30798778Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update). Otolaryngol Head Neck Surg. 2019 Feb;160(1_suppl):S1-S42. doi: 10.1177/0194599818801757.
- Background: PubMed 26436644Ingram DG, Friedman NR. Toward Adenotonsillectomy in Children: A Review for the General Pediatrician. JAMA Pediatr. 2015 Dec;169(12):1155-61. doi: 10.1001/jamapediatrics.2015.2016.
- BackgroundNational Prospective Tonsillectomy Audit Final Report. Royal College of Surgeons https://www.rcseng.ac.uk/library-and-publications/rcs-publications/docs/tonsillectomy-audit/
- Background: PubMed 28607888Alvarez Palacios I, Gonzalez-Orus Alvarez-Morujo R, Alonso Martinez C, Ayala Mejias A, Arenas Britez O. Postoperative Pain in Adult Tonsillectomy: Is There Any Difference Between the Technique? Indian J Otolaryngol Head Neck Surg. 2017 Jun;69(2):187-193. doi: 10.1007/s12070-017-1058-9. Epub 2017 Jan 16.
- Background: PubMed 25241379Lauder G, Emmott A. Confronting the challenges of effective pain management in children following tonsillectomy. Int J Pediatr Otorhinolaryngol. 2014 Nov;78(11):1813-27. doi: 10.1016/j.ijporl.2014.08.011. Epub 2014 Aug 27.
- Background: PubMed 27647717Tobias JD, Green TP, Cote CJ; SECTION ON ANESTHESIOLOGY AND PAIN MEDICINE; COMMITTEE ON DRUGS. Codeine: Time to Say "No". Pediatrics. 2016 Oct;138(4):e20162396. doi: 10.1542/peds.2016-2396. Epub 2016 Sep 19.
- Background: PubMed 25624387Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906.
- BackgroundIsmail Zaidan & Amanda Lent. Post-Tonsillectomy Pain in Children: The Postcodeine Era. US Pharm. 41, 31-34 (2016).
- Background: PubMed 26164211D'Souza JN, Schmidt RJ, Xie L, Adelman JP, Nardone HC. Postoperative nonsteroidal anti-inflammatory drugs and risk of bleeding in pediatric intracapsular tonsillectomy. Int J Pediatr Otorhinolaryngol. 2015 Sep;79(9):1472-6. doi: 10.1016/j.ijporl.2015.05.042. Epub 2015 Jul 2.
- Background: PubMed 23881651Lewis SR, Nicholson A, Cardwell ME, Siviter G, Smith AF. Nonsteroidal anti-inflammatory drugs and perioperative bleeding in paediatric tonsillectomy. Cochrane Database Syst Rev. 2013 Jul 18;2013(7):CD003591. doi: 10.1002/14651858.CD003591.pub3.
- Background: PubMed 20007794Merry AF, Gibbs RD, Edwards J, Ting GS, Frampton C, Davies E, Anderson BJ. Combined acetaminophen and ibuprofen for pain relief after oral surgery in adults: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):80-8. doi: 10.1093/bja/aep338.
- Background: PubMed 16480830Miranda HF, Puig MM, Prieto JC, Pinardi G. Synergism between paracetamol and nonsteroidal anti-inflammatory drugs in experimental acute pain. Pain. 2006 Mar;121(1-2):22-8. doi: 10.1016/j.pain.2005.11.012. Epub 2006 Feb 9.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alternating Acetaminophen and Ibuprofen and Combined Acetaminophen and Ibuprofen in people with Pain, Postoperative and Tonsillar Hypertrophy, run by Washington University School of Medicine 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 4 inclusion and 4 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 11 Jul 2024. 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. 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 11 Jul 2024). 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 Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3 (time frame: up to 3 days following consent). 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 NCT04551196, which also lists 15 linked publications.
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 11 Jul 2024.