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| Name | Class |
|---|---|
| Franciscan Hospital For Children, INC. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Simultaneous post-operative analgesics | Experimental | Participants randomized into this arm will be given simultaneous Ibuprofen and Acetaminophen every 6 hours for 24 hours. |
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| Control Standard of Care | Active Comparator | Participants randomized into this arm will be given Ibuprofen every 6 hours for 24 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | 10 mg/kg/dose of ibuprofen will be given every 6 hours for 24 hours post surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | day of surgery, one pay post surgery, 2 days post surgery, 15 days post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keri Discepolo, DDS MPH | Contact | 617-358-3446 | kdiscep@bu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Keri Discepolo, DDS MPH | BU Goldman School of Dental Medicine, Pediatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franciscan Children's Hospital | Recruiting | Brighton | Massachusetts | 02135 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Acetominophen | Drug | 15 mg/kg/dose of acetominophen will be given every 6 hours for 24 hours post surgery |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |