Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia
Pain, Postoperative
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 4
- Age range
- 4 years - 6 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 28 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- 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
Exclusion Criteria:
- ASA III or IV
- Asthma diagnosis
- Contraindication to acetaminophen or ibuprofen
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
Alternating analgesics
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.
Drug: Ibuprofen · Drug: Acetominophen
Simultaneous post-operative analgesics
Participants randomized into this arm will be given simultaneous Ibuprofen and Acetaminophen every 6 hours for 24 hours.
Drug: Ibuprofen · Drug: Acetominophen
Control Standard of Care
Participants randomized into this arm will be given Ibuprofen every 6 hours for 24 hours.
Drug: Ibuprofen
Ibuprofen DRUG
10 mg/kg/dose of ibuprofen will be given every 6 hours for 24 hours post surgery
Acetominophen DRUG
15 mg/kg/dose of acetominophen will be given every 6 hours for 24 hours post surgery
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Franciscan Children's HospitalBrighton, Massachusetts, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- Boston University
- Study start
- Apr 16, 2025 Actual
- Primary completion
- Mar 19, 2026 Actual
- Study completion
- Mar 19, 2026 Actual
- First posted
- Jan 3, 2025 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study 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
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026