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Last Updated: May 14, 2025

CLINICAL TRIALS PROFILE FOR CHILDREN'S MOTRIN


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All Clinical Trials for Children's Motrin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01604785 ↗ Low-dose Propofol for Pediatric Migraine Completed Oregon Health and Science University Phase 2/Phase 3 2012-11-01 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. 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. 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.
NCT03352115 ↗ Postoperative Oral Corticosteroids Following Tonsillectomy Unknown status Children's Hospital of Michigan Foundation N/A 2018-01-01 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 Unknown status Wayne State University N/A 2018-01-01 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 >Phase >Start Date >Summary

Clinical Trial Conditions for Children's Motrin

Condition Name

Condition Name for Children's Motrin
Intervention Trials
Tonsillectomy 2
Tonsillitis 1
Appendicitis 1
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Condition MeSH

Condition MeSH for Children's Motrin
Intervention Trials
Pain, Postoperative 2
Wounds and Injuries 1
Tonsillitis 1
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Clinical Trial Locations for Children's Motrin

Trials by Country

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

Trials by US State for Children's Motrin
Location Trials
Tennessee 1
Georgia 1
Utah 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 2
Phase 2/Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Children's Motrin
Clinical Trial Phase Trials
Recruiting 2
Unknown status 2
Withdrawn 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
University of Alberta 1
Wayne State University 1
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Sponsor Type

Sponsor Type for Children's Motrin
Sponsor Trials
Other 15
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Children's MOTRIN: Clinical Trials, Market Analysis, and Projections

Introduction

Children's MOTRIN, a formulation of ibuprofen, is a widely used over-the-counter (OTC) medication for relieving minor aches and pains, reducing fever, and treating various common ailments in children. This article delves into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Dosage and Administration

Clinical trials have established the efficacy and safety of Children's MOTRIN in children aged 6 months to 12 years. The recommended dosage is 10 mg/kg every 6 to 8 hours, with a maximum daily dose of 40 mg/kg. These trials have shown that ibuprofen provides effective relief for minor aches and pains, fever, and symptoms associated with the common cold, flu, and other conditions[1][5].

Adverse Effects

Clinical trials have identified various adverse effects associated with ibuprofen, including gastrointestinal issues such as nausea, epigastric pain, and diarrhea, as well as central nervous system effects like dizziness and headache. Less common but more severe adverse effects include gastric or duodenal ulcers, hepatitis, and allergic reactions like anaphylaxis[1].

Comparative Studies

Studies comparing ibuprofen with acetaminophen have highlighted the antipyretic and analgesic properties of both drugs. However, there is a need for more detailed analyses, especially for safety data, and for studies that include a broader global sample of children[4].

Market Analysis

Market Size and Growth

The ibuprofen market, which includes Children's MOTRIN, is projected to grow significantly. By 2033, the market is expected to reach USD 205.6 million, up from USD 97 million in 2023, with a Compound Annual Growth Rate (CAGR) of 7.8% from 2024 to 2033[2].

Market Segmentation

The market is segmented by type, with tablets leading the market share at 41.6% in 2023, followed by capsules and syrups. By application, the segment for rheumatoid arthritis and osteoarthritis commands a significant share of 30.8%, followed by cancer-related applications and pain relief[2].

Key Drivers

The increasing prevalence of chronic pain conditions and the efficacy of ibuprofen are key drivers of market growth. Additionally, a growing aging population and the ease of use of ibuprofen formulations contribute to the market's expansion[2].

Regulatory Challenges

Despite the growth, the market faces regulatory challenges, including stringent approval processes that can limit the introduction of innovative ibuprofen products[2].

Market Projections

Regional Analysis

The ibuprofen market is expected to grow across various regions, including North America, Western Europe, Eastern Europe, Asia-Pacific (APAC), and Latin America. The U.S. and European markets are particularly significant due to high investment in research and development and government support for clinical trials[2].

Competitive Landscape

The competitive landscape is characterized by several key players, with a trend towards partnerships and collaborations to advance service offerings and accelerate clinical trial processes. This is particularly evident in the APAC region, where outsourcing activities among pharmaceutical companies are on the rise[2].

Impact of Pediatric Clinical Trials

Growing Importance

The global pediatric clinical trials market is also growing, with an estimated size of USD 19.9 billion in 2024 and a projected CAGR of 5.25% from 2025 to 2030. This growth is driven by increasing investments in research and development and government support for pediatric clinical trials[3].

Phase I Trials

Phase I trials in pediatric research are expected to see the fastest growth due to their importance in providing data on safety, tolerability, and pharmacokinetics in younger populations. Advancements in technology and innovative trial designs are facilitating these studies[3].

Consumer Preferences and Brand Reliability

Product Formulations

Children's MOTRIN is available in various formulations, including liquid suspensions, which are popular for their ease of administration and kid-friendly flavors. The enclosed dosing cup makes it easy for parents to accurately dose the medication[5].

Brand Trust

MOTRIN has a long history of providing effective pain and fever relief, making it a trusted brand for families. The reliability and effectiveness of MOTRIN products contribute to their market success[5].

Key Takeaways

  • Clinical Trials: Children's MOTRIN has been proven effective in clinical trials for relieving minor aches and pains, and reducing fever in children.
  • Market Growth: The ibuprofen market, including Children's MOTRIN, is projected to grow at a CAGR of 7.8% from 2024 to 2033.
  • Market Segmentation: The market is segmented by type and application, with tablets and rheumatoid arthritis/osteoarthritis segments leading.
  • Regulatory Challenges: Stringent regulatory processes pose challenges to the introduction of new ibuprofen products.
  • Pediatric Clinical Trials: The pediatric clinical trials market is growing, driven by increased investment and government support.
  • Consumer Preferences: Children's MOTRIN's ease of use and trusted brand reputation contribute to its market success.

FAQs

What is the recommended dosage of Children's MOTRIN for children?

The recommended dosage is 10 mg/kg every 6 to 8 hours, with a maximum daily dose of 40 mg/kg[1].

What are the common adverse effects of Children's MOTRIN?

Common adverse effects include gastrointestinal issues like nausea and diarrhea, as well as central nervous system effects like dizziness and headache[1].

How is the ibuprofen market expected to grow?

The ibuprofen market is expected to grow at a CAGR of 7.8% from 2024 to 2033, reaching USD 205.6 million by 2033[2].

What drives the growth of the ibuprofen market?

The growth is driven by increasing chronic pain conditions, the efficacy of ibuprofen, and a growing aging population[2].

What is the significance of pediatric clinical trials for ibuprofen?

Pediatric clinical trials are crucial for providing data on safety, tolerability, and pharmacokinetics in younger populations, and their growth is supported by increased investment and government support[3].

Why is MOTRIN a trusted brand for families?

MOTRIN has a long history of providing effective pain and fever relief, making it a reliable choice for families[5].

Sources

  1. *Product Monograph Children's MOTRIN Suspension**. McNeil Customer Healthcare.
  2. Ibuprofen Market Size, Share, Growth | CAGR Of 7.8%. Market.US.
  3. Pediatric Clinical Trials Market Size And Share Report, 2030. Grand View Research.
  4. Efficacy and Safety of Acetaminophen vs Ibuprofen for Treating Children's Pain or Fever. JAMA Pediatrics.
  5. Children's MOTRINĀ® Ibuprofen Liquid Medicine for Fever & Pain. MOTRIN.
Last updated: 2025-01-01

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