Pain, PostoperativePhase 4NCT06757075
Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia
A Phase 4 study testing Ibuprofen and Acetominophen in people with Pain, Postoperative, run by Boston University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effectiveness of various oral analgesic regimens in minimizing post-operative pain and discomfort in young children following dental rehabilitation under general anesthesia (DRGA). Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ibuprofen and Acetominophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2025to Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists (ASA) I-II
- Requiring Oral Rehabilitation under General Anesthesia
- Possess legal guardians proficient in English
- Not have a history of any adverse/allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) or Acetaminophen
Who cannot join
- ASA III or IV
- Asthma diagnosis
- Contraindication to acetaminophen or ibuprofen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Franciscan Children's Hospital
Brighton, Massachusetts, 02135
Keri Discepolo, DDS MPH, 617-358-3446, kdiscep@bu.edu
About this study
Official title: A Comparison of Standard Dose of Ibuprofen Alone, Alternating, or Combined With Acetaminophen for the Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia
The purpose of this study is to investigate the effectiveness of various oral analgesic regimens in minimizing post-operative pain and discomfort in young children following dental rehabilitation under general anesthesia (DRGA). In this randomized controlled trial, three analgesic regimens following DRGA in Franciscan Children's Hospital will be compared using both self-report and behavioral measures.
The analgesic therapies to be investigated are ibuprofen monotherapy, alternating ibuprofen and acetaminophen dual-therapy, and combined ibuprofen and acetaminophen dual-therapy. For the purposes of this study, combined therapy is defined as the simultaneous administration of acetaminophen and ibuprofen at regular intervals, whereas alternating therapy is defined as one analgesic (acetaminophen or ibuprofen) administered within a 3 hour interval of the other.
- Conditions
- Pain, Postoperative
- Being tested
- Ibuprofen, Acetominophen
- Keywords
- Dental rehabilitation under general anesthesia (DRGA), Dental surgery patients 4-6 years, Acetominophen, Ibuprofen, Pacing analgesics
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Motrin
10 mg/kg/dose of ibuprofen will be given every 6 hours for 24 hours post surgery
AcetominophenDrug
Also called Tylenol
15 mg/kg/dose of acetominophen will be given every 6 hours for 24 hours post surgery
| Study group | Role | What they receive |
|---|---|---|
| Alternating analgesics | Experimental | Participants randomized into this arm will be given alternating Ibuprofen and Acetaminophen every 6 hours, alternating the two medications every 3 hours: first dose ibuprofen, three hours later acetaminophen for 24 hours. Receives: Drug: Ibuprofen; Drug: Acetominophen |
| Simultaneous post-operative analgesics | Experimental | Participants randomized into this arm will be given simultaneous Ibuprofen and Acetaminophen every 6 hours for 24 hours. Receives: Drug: Ibuprofen; Drug: Acetominophen |
| Control Standard of Care | Active comparator | Participants randomized into this arm will be given Ibuprofen every 6 hours for 24 hours. Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental discomfort assessed by the abbreviated DDQ-8
The Dental Discomfort Questionnaire (DDQ-8)-Abbreviated is an 8 item questionnaire completed by the caregiver. Responses to each question are Yes=2 and No=0 creating a possible range of total scores of 0-16 with higher scores correlated with more dental discomfort.
Measured: day of surgery, one pay post surgery, 2 days post surgery, 15 days post surgery
Pain assessment based on the FLACC
The Face, Legs, Activity, Cry, and Consolability (FLACC) scale assesses pain by the caregiver on 5 aspects of behavior: (F) facial expression; (L) leg movement; (A) activity; (C) cry; (C) consolability. Each behavior is rated 0 to 2 resulting in a range of scores from 0 to 10 with higher scores correlated with more pain.
Measured: day of surgery, one pay post surgery, 2 days post surgery, 15 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start16 Apr 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Franciscan Hospital For Children, INC.
- Responsible party
- Sponsor
- Investigators
- Keri Discepolo, DDS MPH, Principal investigator, BU Goldman School of Dental Medicine, Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757075
- Sponsor's protocol ID
- H-001FC
- Status last verified
- Aug 2026
- First submitted
- 24 Dec 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Standard Dose of Ibuprofen Alone, Alternating, or Combined With Acetaminophen for the Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia
- ClinicalTrials.gov ID
- NCT06757075
- Acronym / sponsor ID
- H-001FC
- Conditions
- Pain, Postoperative
- Keywords
- Dental rehabilitation under general anesthesia (DRGA), Dental surgery patients 4-6 years, Acetominophen, Ibuprofen, Pacing analgesics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Franciscan Hospital For Children, INC.
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effectiveness of various oral analgesic regimens in minimizing post-operative pain and discomfort in young children following dental rehabilitation under general anesthesia (DRGA). In this randomized controlled trial, three analgesic regimens following DRGA in Franciscan Children's Hospital will be compared using both self-report and behavioral measures.
The analgesic therapies to be investigated are ibuprofen monotherapy, alternating ibuprofen and acetaminophen dual-therapy, and combined ibuprofen and acetaminophen dual-therapy. For the purposes of this study, combined therapy is defined as the simultaneous administration of acetaminophen and ibuprofen at regular intervals, whereas alternating therapy is defined as one analgesic (acetaminophen or ibuprofen) administered within a 3 hour interval of the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alternating analgesics | Experimental | Drug: Ibuprofen, Drug: AcetominophenParticipants randomized into this arm will be given alternating Ibuprofen and Acetaminophen every 6 hours, alternating the two medications every 3 hours: first dose ibuprofen, three hours later acetaminophen for 24 hours. |
| Simultaneous post-operative analgesics | Experimental | Drug: Ibuprofen, Drug: AcetominophenParticipants randomized into this arm will be given simultaneous Ibuprofen and Acetaminophen every 6 hours for 24 hours. |
| Control Standard of Care | Active comparator | Drug: IbuprofenParticipants randomized into this arm will be given Ibuprofen every 6 hours for 24 hours. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) I-II
- Requiring Oral Rehabilitation under General Anesthesia
- Possess legal guardians proficient in English
- Not have a history of any adverse/allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) or Acetaminophen
Key exclusion criteria (3 listed)
- ASA III or IV
- Asthma diagnosis
- Contraindication to acetaminophen or ibuprofen
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 |
|---|---|---|
| IbuprofenAlso: Motrin10 mg/kg/dose of ibuprofen will be given every 6 hours for 24 hours post surgery | Drug | Alternating analgesics, Control Standard of Care, Simultaneous post-operative analgesics |
| AcetominophenAlso: Tylenol15 mg/kg/dose of acetominophen will be given every 6 hours for 24 hours post surgery | Drug | Alternating analgesics, Simultaneous post-operative analgesics |
Primary outcome
Dental discomfort assessed by the abbreviated DDQ-8
Time frame: day of surgery, one pay post surgery, 2 days post surgery, 15 days post surgery
The Dental Discomfort Questionnaire (DDQ-8)-Abbreviated is an 8 item questionnaire completed by the caregiver. Responses to each question are Yes=2 and No=0 creating a possible range of total scores of 0-16 with higher scores correlated with more dental discomfort.
Pain assessment based on the FLACC
Time frame: day of surgery, one pay post surgery, 2 days post surgery, 15 days post surgery
The Face, Legs, Activity, Cry, and Consolability (FLACC) scale assesses pain by the caregiver on 5 aspects of behavior: (F) facial expression; (L) leg movement; (A) activity; (C) cry; (C) consolability. Each behavior is rated 0 to 2 resulting in a range of scores from 0 to 10 with higher scores correlated with more pain.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Keri Discepolo, DDS MPH principal investigator
BU Goldman School of Dental Medicine, Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen and Acetominophen in people with Pain, Postoperative, run by Boston University 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 3 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rua Milaeh, DDS MPH (617-358-3446, milaeh@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental discomfort assessed by the abbreviated DDQ-8 (time frame: day of surgery, one pay post surgery, 2 days post surgery, 15 days post surgery). The study lists 2 primary outcomes in all. 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 12 Aug 2026.