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Generated: June 26, 2019

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CLINICAL TRIALS PROFILE FOR CHILDREN'S MOTRIN

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Clinical Trials for Children's Motrin

Trial ID Title Status Sponsor Phase Summary
NCT01604785 Low-dose Propofol for Pediatric Migraine Completed Oregon Health and Science University Phase 2/Phase 3 There has been little advancement in abortive migraine therapies in recent decades, and few proven treatments exist for acute migraine, particularly in children. Propofol, a general anesthetic, has been suggested to be effective for the treatment of migraine headaches in adults when used in subanesthetic doses (lower doses than those used for anesthesia or sedation). Initial retrospective review of the investigators experience with propofol for migraine in children suggests that it is safe and may be more effective than standard treatments used in the emergency department. The investigators retrospective series had a small subject population and a larger study is needed to compare propofol to current available treatments. All subjects presenting to the pediatric emergency department with signs/symptoms of migraine headache will be screened for the study. Subjects who are eligible will be provided information about the study and consent/assent forms from a member of the research team, and asked whether they are interested in participating. All study subjects will receive acetaminophen (Tylenol) or ibuprofen (Motrin) for their headache if they have not already tried these first-line treatments at home; those with persistent symptoms requiring further treatment who consent to participate in the study will be randomized to receive either standard treatment or propofol. Standard treatment currently consists of a "cocktail" of medications that include anti-nausea medicines (metoclopramide and diphenhydramine) and an analgesic (ketorolac) as well as intravenous fluids. Subjects assigned to the experimental group (Propofol) will receive the same intravenous fluids and up to five doses of propofol. All subjects will undergo assessment of their pain (self-rated on a scale from 0-10) before and after treatment. During treatment they will have close monitoring of their vital signs. No additional laboratory tests or procedures are involved. Post-visit clinical data will be collected from the subject's medical record and subjects will be called by telephone 24-48 hours after discharge from the emergency department to ask how they are doing and whether they required any additional treatments such as home medications or by other medical professionals other than OHSU. The study data will be presented in summary tables that outline subjects' clinical presentation prior to treatments, and response to study drug during their visit. The main variables of interest include effectiveness (determined as a reduction in self-reported pain score), length of stay in the pediatric emergency department, recurrent headache requiring emergency treatment within 24 hours and whether any adverse effects occur. These will be compared between the 2 study groups with basic statistics.
NCT01797575 N-Acetyl Cysteine and Aspirin as an Adjunctive Treatment for Bipolar Disorder Recruiting Stanley Medical Research Institute Phase 2 We propose to conduct a double-blind placebo-controlled trial with a widely available and prototypical non-steroidal anti-inflammatory agent, aspirin, and an antioxidant agent, NAC, involving symptomatic Bipolar Disorder type I and II patients having a depressive or mixed episode currently. This will be the first controlled study to test the hypothesis that aspirin and NAC, by themselves or in combination, will be beneficial in treating depression in bipolar disorder patients and in promoting mood stabilization. Our study has the following Aims: Aim I - Examine efficacy of aspirin in treating depression in bipolar patients in a double-blind placebo-controlled add-on design; Aim II - Examine efficacy of NAC in treating depression in bipolar patients in a double-blind placebo-controlled add-on design; Aim III - Examine efficacy of combined treatment with aspirin and NAC looking for synergistic, potentiating effects; Aim IV - Examine the role of markers of neuroinflammation, as possible mediators or modulators in therapeutic response in the treatment of depression in patients with Bipolar Disorder.
NCT01797575 N-Acetyl Cysteine and Aspirin as an Adjunctive Treatment for Bipolar Disorder Recruiting The University of Texas Health Science Center, Houston Phase 2 We propose to conduct a double-blind placebo-controlled trial with a widely available and prototypical non-steroidal anti-inflammatory agent, aspirin, and an antioxidant agent, NAC, involving symptomatic Bipolar Disorder type I and II patients having a depressive or mixed episode currently. This will be the first controlled study to test the hypothesis that aspirin and NAC, by themselves or in combination, will be beneficial in treating depression in bipolar disorder patients and in promoting mood stabilization. Our study has the following Aims: Aim I - Examine efficacy of aspirin in treating depression in bipolar patients in a double-blind placebo-controlled add-on design; Aim II - Examine efficacy of NAC in treating depression in bipolar patients in a double-blind placebo-controlled add-on design; Aim III - Examine efficacy of combined treatment with aspirin and NAC looking for synergistic, potentiating effects; Aim IV - Examine the role of markers of neuroinflammation, as possible mediators or modulators in therapeutic response in the treatment of depression in patients with Bipolar Disorder.
NCT03352115 Postoperative Oral Corticosteroids Following Tonsillectomy Not yet recruiting Children's Hospital of Michigan Foundation N/A Tonsillectomy is one of the most common surgical procedures in the United States, and post-operative pain management is a challenge for otolaryngologists. A 2013 black-box warning on codeine following tonsillectomy has drawn attention to potential concerns with all narcotics in these patients, and many surgeons try to avoid narcotics. The use of intra-operative corticosteroids has been proven to be beneficial in reducing post-operative morbidity, and some small studies have shown possible benefit to the use of post-operative oral corticosteroids as well, although the results of these studies are mixed. To date, no one has looked at whether the use of post-operative oral steroids may reduce or eliminate the need for narcotics. We aim to determine whether the addition of oral steroids to our post-operative pain regimen can reduce the need for narcotic pain medications.
NCT03352115 Postoperative Oral Corticosteroids Following Tonsillectomy Not yet recruiting Wayne State University N/A Tonsillectomy is one of the most common surgical procedures in the United States, and post-operative pain management is a challenge for otolaryngologists. A 2013 black-box warning on codeine following tonsillectomy has drawn attention to potential concerns with all narcotics in these patients, and many surgeons try to avoid narcotics. The use of intra-operative corticosteroids has been proven to be beneficial in reducing post-operative morbidity, and some small studies have shown possible benefit to the use of post-operative oral corticosteroids as well, although the results of these studies are mixed. To date, no one has looked at whether the use of post-operative oral steroids may reduce or eliminate the need for narcotics. We aim to determine whether the addition of oral steroids to our post-operative pain regimen can reduce the need for narcotic pain medications.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Children's Motrin

Condition Name

Condition Name for Children's Motrin
Intervention Trials
Tonsillectomy 2
Migraine Headache 1
Bipolar Disorder 1
Appendicitis 1
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Condition MeSH

Condition MeSH for Children's Motrin
Intervention Trials
Pain, Postoperative 2
Disease 1
Bipolar Disorder 1
Migraine Disorders 1
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Clinical Trial Locations for Children's Motrin

Trials by Country

Trials by Country for Children's Motrin
Location Trials
United States 4
Canada 1
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Trials by US State

Trials by US State for Children's Motrin
Location Trials
Georgia 1
Utah 1
Texas 1
Oregon 1
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Clinical Trial Progress for Children's Motrin

Clinical Trial Phase

Clinical Trial Phase for Children's Motrin
Clinical Trial Phase Trials
Phase 4 1
Phase 2/Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Children's Motrin
Clinical Trial Phase Trials
Recruiting 3
Not yet recruiting 2
Completed 1
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Clinical Trial Sponsors for Children's Motrin

Sponsor Name

Sponsor Name for Children's Motrin
Sponsor Trials
Children's Hospital of Michigan Foundation 1
The Hospital for Sick Children 1
The University of Texas Health Science Center, Houston 1
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Sponsor Type

Sponsor Type for Children's Motrin
Sponsor Trials
Other 15
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