A Phase 4 interventional study of Ibuprofen and Acetominophen in Pain, Postoperative, sponsored by Boston University. Completed at 1 site in United States. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Boston University · Phase 4, Interventional, and Treatment
Among 1,180 studies in Pain, Postoperative with a site in United States — 204 open to participants now, 237 under way, 26 of them phase 3. Pain, Postoperative · United States.
Among the 1,180 studies in Pain, Postoperative with a site in United States, this one is the 893rd largest by enrollment of the 1,098 interventional ones, is one of 49 that started in 2025, is one of 359 in phase 4, and was the 1,068th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 28 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →204 of the 1,180 studies in Pain, Postoperative with a site in United States are open now, in 8 countries. Each count lists the studies.
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 4 Years to 6 Years · all sexes · no healthy volunteers.
The full table on the hub →1,180 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 49 started in 2025.
Median enrollment 76 across the 1,098 interventional studies, 130 across the 82 observational. Of the 783 that completed or were terminated, 474 (61%) have results posted.
199 of 1,180 have an industry lead sponsor. The 10 most frequent:
Boston University is the lead sponsor of 270 studies on the registry; 36 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.
Boston University has 4 studies filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
97 of the studies in Pain, Postoperative with a site in United States that are under way reach primary completion within a year, 13 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07060495Phase 3Rutgers, The State University of New JerseyRADA16 for Adult Tonsillectomy | 2026-12-01 |
| NCT07539623Phase 3Icahn School of Medicine at Mount SinaiSuzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery | 2026-12-22 |
| NCT07226076Phase 3Medical University of South CarolinaMethadone in TKA for Post-op Pain and Opioid Reduction | 2026-12-28 |
| NCT07565870Phase 3Alexandre P. JoostenMethadone for Enhanced Postoperative Analgesia in Intermediate-Risk Noncardiac Surgery (MELODY) | 2026-12-31 |
| NCT05058287Phase 3Hospital for Special Surgery, New YorkLumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression | 2026-12-31 |
Among the 1,180 studies in Pain, Postoperative with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants randomized into this arm will be given simultaneous Ibuprofen and Acetaminophen every 6 hours for 24 hours.
Drug: Ibuprofen · Drug: Acetominophen
Participants randomized into this arm will be given Ibuprofen every 6 hours for 24 hours.
Drug: Ibuprofen
10 mg/kg/dose of ibuprofen will be given every 6 hours for 24 hours post surgery
Also known as: Motrin
15 mg/kg/dose of acetominophen will be given every 6 hours for 24 hours post surgery
Also known as: Tylenol
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.
Time frame: 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.
Time frame: day of surgery, one pay post surgery, 2 days post surgery, 15 days post surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2025 to primary completion in Mar 2026, 11 months.
Of 531 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's 11 months is below that.
Counting every sponsor, half of 541 studies reached it within 16 months; a quarter within 8 and three quarters within 32.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: primary completion Mar 2027 → Mar 2026 and completion Mar 2027 → Mar 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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