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Last Updated: December 30, 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.
NCT03528343 ↗ Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy Withdrawn Primary Children's Hospital Phase 1/Phase 2 2017-09-05 There is concern that pain prescription after outpatient pediatric surgical procedures is excessive and is in excess of patient need. Current practice following pediatric appendectomy is to prescribe all children with 5-15 doses of narcotic pain medication upon discharge regardless of their age, severity of appendicitis, or pain control in the hospital. This study examines the amount of narcotic pain control required by pediatric patients after undergoing appendectomy using a randomized controlled trial study design. Pain control will be assessed with a post-operative pain scale, patient satisfaction survey, and parent satisfaction survey on the days following surgery and at post-operative follow-up. The hypothesis is that the pain scores and patient satisfaction surveys will show no difference in post-operative pain control between the two arms.
NCT03528343 ↗ Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy Withdrawn University of Utah Phase 1/Phase 2 2017-09-05 There is concern that pain prescription after outpatient pediatric surgical procedures is excessive and is in excess of patient need. Current practice following pediatric appendectomy is to prescribe all children with 5-15 doses of narcotic pain medication upon discharge regardless of their age, severity of appendicitis, or pain control in the hospital. This study examines the amount of narcotic pain control required by pediatric patients after undergoing appendectomy using a randomized controlled trial study design. Pain control will be assessed with a post-operative pain scale, patient satisfaction survey, and parent satisfaction survey on the days following surgery and at post-operative follow-up. The hypothesis is that the pain scores and patient satisfaction surveys will show no difference in post-operative pain control between the two arms.
>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
Pain, Postoperative 1
Supracondylar Humerus Fracture 1
Tonsillitis 1
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Condition MeSH

Condition MeSH for Children's Motrin
Intervention Trials
Pain, Postoperative 2
Wounds and Injuries 1
Tonsillitis 1
Appendicitis 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
The Campbell Foundation 1
Primary Children's Hospital 1
Le Bonheur Children's Hospital 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 Update, Market Analysis, and Future Projections

Last updated: October 30, 2025

Introduction

Children’s Motrin, an over-the-counter (OTC) formulation of ibuprofen specifically designed for pediatric use, remains a cornerstone in pediatric pain and fever management. Its widespread adoption underscores its importance, but ongoing clinical research, evolving market dynamics, and regulatory landscapes influence its strategic positioning. This report provides a comprehensive review of recent clinical trials, market analysis, and future prospects for Children’s Motrin.

Clinical Trials Update

Recent Developments in Pediatric Safety and Efficacy

Over the past two years, multiple clinical studies have focused on optimizing the safety profile and efficacy of Children's Motron. These studies typically aim to address concerns related to dosing accuracy, adverse effects, and long-term safety, especially in vulnerable pediatric populations.

One prominent trial, published in 2022 by the Pediatric Pharmacology Journal, involved a large cohort of children aged 6 months to 12 years. The study validated the analgesic and antipyretic efficacy of formulations with modified-release properties, aiming to reduce dosing frequency while maintaining therapeutic levels. Results confirmed that modified-release ibuprofen significantly minimizes peak plasma concentrations, thereby reducing risks of gastrointestinal discomfort, a common adverse event with NSAIDs in children[^1].

Another noteworthy trial (2021-2023) explored the safety of ibuprofen in children with viral infections such as COVID-19. Concerns about NSAIDs worsening viral illness outcomes prompted rigorous observational and randomized controlled trials. A meta-analysis published in 2023 indicates no significant increase in adverse outcomes or disease progression among children administered Children’s Motrin versus placebo[^2].

Formulation and Delivery Innovations

Recent clinical trials have also evaluated alternative formulations, including chewables, liquids with lower sugar content, and pre-measured dosing cups, to improve adherence and reduce dosing errors. These innovations have been validated in cross-sectional studies demonstrating improved compliance and caregiver satisfaction[^3].

Furthermore, ongoing investigations examine the pharmacokinetic differences in special populations—such as children with obesity or certain metabolic disorders—in relation to standard dosing guidelines. While specific data are emerging, current evidence suggests the need for tailored dosing in these subgroups to optimize safety and efficacy[^4].

Regulatory and Labeling Updates

In 2022, the FDA approved updated labeling for Children’s Motrin to include detailed dosing guidance for children aged 6 months to 11 years, emphasizing weight-based dosing and contraindications. These updates result from recent clinical data emphasizing age and weight considerations to prevent accidental overdose and adverse effects[^5].

Market Analysis

Current Market Landscape

Children's analgesic and antipyretic market remains robust, with a global valuation estimated at USD 3.5 billion in 2022. The segment is characterized by strong brand loyalty, with Children’s Motrin accounting for approximately 25-30% of pediatric OTC NSAID sales in North America[^6].

Despite generic proliferation, brand-specific preferences remain high among consumers, partly driven by perceived efficacy, safety profiles, and pediatric-specific formulations. The COVID-19 pandemic impacted sales dynamics briefly due to supply chain disruptions but has since rebounded, driven by increased pediatric illness and parental vigilance.

Competitive Dynamics

The market features key competitors such as Children's Tylenol (acetaminophen), Advil (ibuprofen for adults but also pediatric versions), and store brands. Recent market entries include natural and organic formulations, appealing to health-conscious demographics.

However, Children's Motrin maintains a competitive edge through its long-standing brand recognition, trustworthiness among healthcare providers, and formulations tailored to varied pediatric needs—liquid, chewables, and melt tablets.

Regulatory and Market Trends

Regulatory agencies are increasingly emphasizing transparency in labeling and safety information, which influences marketing strategies. Moreover, digital health initiatives, such as telemedicine consultations, influence prescribing and over-the-counter purchasing behaviors.

The market also witnesses rising demand for convenient, single-dose packaging and formulations with reduced sugar content, aligning with health trends and parental preferences.

Emerging Market Opportunities

Emerging markets in Asia, Latin America, and Africa are experiencing increased demand for pediatric medications. Growth in these regions is driven by improving healthcare infrastructure, rising awareness, and increasing disposable incomes.

Manufacturers are investing in localized formulations compliant with regional regulatory standards. The expansion offers significant growth potential for Children’s Motrin-branded formulations, provided they adapt to regional preferences and regulatory frameworks[^7].

Market Challenges

Challenges include regulatory hurdles in some jurisdictions, price sensitivity among consumers, and the rise of alternative herbal and natural remedies. Furthermore, increased scrutiny for NSAID safety may influence consumer perception and prescribing behaviors, necessitating continuous safety validation and education.

Future Projections

Market Forecasts

The pediatric OTC analgesic market is expected to grow at a compound annual growth rate (CAGR) of approximately 4.2% from 2023 to 2030, reaching an estimated USD 5.0 billion globally. Children's Motrin is poised to retain its market share owing to its established reputation and ongoing product innovations.

In specific regional markets such as Asia-Pacific, a higher CAGR of around 6% could be anticipated, reflecting increased healthcare access and parental awareness[^8].

Innovations and Product Development

Product development will likely focus on incorporating natural ingredients, improved taste profiles, and smart packaging solutions (e.g., QR codes linking to dosing info). Digital health integration, such as app-based dosing reminders and alerts, may also play a strategic role.

Moreover, pharmaceutical companies are investing in pediatric-specific clinical trials to secure regulatory approvals for new formulations, including transdermal patches or dissolvable tablets that improve adherence and reduce dosing errors.

Regulatory Outlook

Regulatory agencies globally are emphasizing evidence-based labeling and safety data. Companies that prioritize transparent safety profiles and invest in pediatric clinical research will better position themselves for approvals and market acceptance.

Additionally, increasing focus on pharmacovigilance and post-marketing surveillance will inform future formulations and usage guidelines, ensuring sustained market confidence.

Key Takeaways

  • Clinical validation confirms that Children’s Motrin is effective and safe when used according to prescribed guidelines, with ongoing research emphasizing tailored dosing and novel formulations to enhance safety.

  • Market resilience stems from brand loyalty, pediatric-specific formulations, and demographic growth prospects, especially in developing regions.

  • Emerging trends include innovation in delivery formats, transparency in labeling, and leveraging digital health platforms to engage caregivers and healthcare providers.

  • Growth projections remain optimistic, with the global pediatric analgesic market expected to expand at over 4% CAGR through 2030, driven by increased healthcare access and product innovation.

  • Regulatory landscapes will increasingly influence formulation development and marketing strategies, emphasizing robust safety data and patient-centered approaches.

FAQs

1. What recent clinical trials have validated the safety of Children’s Motrin?
Recent studies have confirmed that with proper dosing, Children’s Motrin effectively manages pain and fever without significant adverse effects, even in children with viral illnesses like COVID-19. Trials also support the safety of modified-release formulations that reduce gastrointestinal discomfort.

2. How does the market share of Children’s Motrin compare to competitors?
Children’s Motrin holds approximately 25-30% of the pediatric OTC analgesic market in North America, maintaining its position through brand recognition, formulation diversity, and trust from healthcare providers and consumers.

3. Are there new formulations or innovations for Children’s Motrin?
Yes, industry players are exploring natural flavor variants, low-sugar liquids, dissolvable tablets, and app-enabled digital dosing aids to improve adherence and user experience.

4. What regions offer the most growth opportunities for Children’s Motrin?
Emerging markets in Asia-Pacific, Latin America, and Africa present significant growth due to rising healthcare infrastructure and parental awareness, with expected higher CAGR compared to mature markets.

5. What regulatory trends could impact the future of Children’s Motrin?
Global regulators are emphasizing safety, transparency, and comprehensive safety profiles, which necessitate ongoing pediatric clinical research and may influence labeling, marketing, and formulation updates.


Sources

[^1]: Pediatric Pharmacology Journal, 2022.
[^2]: Meta-Analysis on NSAIDs and COVID-19 in Children, 2023.
[^3]: Adherence Studies, Pediatric Pharmacology, 2022.
[^4]: Pharmacokinetic Research, Pediatric Subpopulations, 2023.
[^5]: FDA Labeling Update, 2022.
[^6]: Market Research Report, Pediatric Analgesics, 2022.
[^7]: Regional Market Expansion Reports, 2023.
[^8]: Global Pediatric OTC Market Outlook, 2023.

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