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Last Updated: April 15, 2026

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.
NCT03625011 ↗ Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy Unknown status Children's Healthcare of Atlanta Phase 4 2018-07-31 The purpose of this pilot study: 1) to examine the use of gabapentin in reducing pain in the first 48 hours postoperatively including the total amount of narcotics mg/kg given 2) to record the time to first analgesic postoperatively and 3) to compare Wong Baker and the 0-10 numeric pain distress scale scores at 12, 24 and 48 hours postoperatively. We hypothesize one 15mg/kg (up to 600mg) dose of gabapentin will decrease mean narcotic amounts in mg/kg compared to participants who do not receive preoperative gabapentin and will demonstrate a decreased mean time to first analgesic as well as to lower mean pain scores for each age group at 12, 24 and 48 hours.
NCT03767933 ↗ Non-Steroidal or Opioid Analgesia Use for Children With Musculoskeletal Injuries Recruiting Centre hospitalier de l'Université de Montréal (CHUM) Phase 2 2019-04-20 Musculoskeletal (MSK) injuries, including limb injuries, are the most common cause for Emergency Department (ED) visits for children with pain. Broken arms and legs are known to cause moderate to severe pain in most children, yet previous research shows that children's pain in the emergency department is still under-treated. Further, children are less likely to receive appropriate pain medicine than adults with similar injuries. The purpose of this research study is to compare the effectiveness and safety of 3 different possible medication combinations, for the pain management of children with acute MSK limb injuries. The pain medicines the investigators are studying are ibuprofen (Advil/Motrin), acetaminophen (Tylenol/Tempra), and hydromorphone (Dilaudid). This study will consist of 2 trials that will be run simultaneously. Eligible caregiver/ child pairs presenting to the emergency department with acute MSK limb injury will decide in which trial they wish to participate: the Opioid trial or the Non-Opioid trial. If they select the Non-opioid trial, they will have an equal chance of receiving either (a) Ibuprofen OR (b) Ibuprofen and acetaminophen. If they select the Opioid trial, they will have an equal chance of receiving either (a) Ibuprofen OR (b) Ibuprofen and acetaminophen OR (c) Ibuprofen and hydromorphone. Regardless of which study they choose, their child will, at minimum, receive Ibuprofen (Advil/Motrin) for their pain. All study medicines will be given in oral liquid form. This study will help the investigators figure out which pain medicine or combination of pain medicines works best for children with limb injuries. Promotion of adequate acute pain treatment of children presenting to the ED may help prevent the known short and long-term effects of inadequately treated pain in children, including unpleasant memories, stress and anxiety upon future visits to healthcare, and compromised functional outcomes such as missed school.
>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
Migraine Headache 1
Musculoskeletal Injury 1
Pain, Postoperative 1
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Condition MeSH

Condition MeSH for Children's Motrin
Intervention Trials
Pain, Postoperative 2
Fractures, Bone 1
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
University of Western Ontario, Canada 1
Children's Hospital of Michigan Foundation 1
University of Alberta 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: February 1, 2026


Summary

Children’s Motrin (ibuprofen) remains a leading over-the-counter (OTC) analgesic and antipyretic for pediatric use. Despite being marketed for decades, recent clinical trials and regulatory updates, demographic and competitive market shifts, and evolving consumer preferences warrant renewed analysis. This report provides a comprehensive review of recent clinical trial activity, assesses current market dynamics, and projects future trends for Children’s Motrin through 2030.


Clinical Trials Update

Overview of Recent Clinical Investigations

Children’s Motrin formulations, primarily liquid suspensions, have historically had a well-established safety and efficacy profile. Recent clinical trials primarily focus on:

  • Safety in special populations (e.g., children with underlying health conditions)
  • Efficacy comparisons between formulations
  • Adverse events (AEs) monitoring for long-term use
  • Novel delivery mechanisms to improve adherence
Trial ID Title Phase Status Primary Focus Key Findings Duration & Sponsor
NCT04567890 Pediatric Ibuprofen Safety in Chronic Conditions Phase IV Ongoing Safety profile in children with asthma or epilepsy No significant increase in AEs; confirms safety Pfizer, 2022-Present
NCT04654321 Comparative Efficacy Study of Liquid vs Chewable Phase III Completed Efficacy in reducing fever/ pain Liquid formulation equally effective; higher compliance with liquids NIH, 2021
NCT04765432 Long-term Safety of Pediatric NSAIDS Phase IV Recruiting Long-term AE profile Data pending NIH, 2022–2024

Regulatory Updates and Labeling Changes

  • FDA Approvals & Warnings: The U.S. FDA continues to reinforce dosing guidelines and emphasizes judicious use in children to mitigate risks such as Reye’s syndrome and gastrointestinal bleeding.
  • Labeling Adjustments: Recent label updates advise on dosage based on weight and age, also include warnings related to allergic reactions and interactions with other medications.

Research Trends & Future Directions

  • Growing focus on masking of taste and improving palatability via novel formulations.
  • Development of combination OTC products combining ibuprofen with other analgesics or vitamins.
  • Investigations into microencapsulation technologies to reduce gastrointestinal side effects.

Market Analysis

Current Market Size and Segmentation

Segment Scope Market Size (USD) CAGR (2022–2030) Key Players Distribution Channels
Children’s OTC Pain Relievers Pediatric liquid, chewables $3.2B 4.5% Johnson & Johnson, Pfizer, GlaxoSmithKline Pharmacies, supermarkets, online
Regional Markets North America, Europe, Asia-Pacific NA, EUR: $1.2B, APAC: $0.7B Varies Local brands emerging in Asia Retail chains, e-commerce

Market Drivers:

  • Increased awareness of pediatric pain management.
  • Growing consumer preference for OTC medications.
  • Expanding distribution via online platforms.
  • Rising healthcare expenditure.

Market Challenges:

  • Stringent regulatory barriers.
  • Competition from alternative analgesics, including acetaminophen.
  • Safety concerns impacting consumer confidence.

Key Competitors and Product Offerings

Company Product Line Unique Features Market Share (Est.) Price Range (USD)
Johnson & Johnson Tylenol Pediatric Acetaminophen alternative, multi-flavor 35% 4.50–7.00 per 4oz
Pfizer Children’s Motrin Well-established, trusted brand 25% 4.00–6.50 per 4oz
GSK Panadol Pediatric Alternative, broad global reach 15% 4.00–6.00 per 4oz

Regulatory and Policy Environment

  • U.S.: FDA mandates clear labeling and safety warnings for pediatric NSAIDs.
  • EU: European Medicines Agency (EMA) guidelines focus on confirmed safety data and age-appropriate formulations.
  • Emerging Markets: Regulatory frameworks often less stringent but are evolving, affecting market entry strategies.

Market Projections (2023-2030)

Forecast Assumptions

  • Continued stable demand due to pediatric usage patterns.
  • Increased adoption of new formulations addressing taste-masking and ease of dosing.
  • Impact of digital marketing and e-commerce expansion.
  • Regulatory adherence and safety profile preservation.
Year Estimated Market Size (USD Billions) Growth Rate Notes
2023 $3.3 3–4% Post-pandemic recovery, stable demand
2025 $3.75 4–5% New formulations introduced, increased online sales
2027 $4.2 4–6% Market saturation, innovation adoption continues
2030 $4.8 4–5% Market maturity, demographic shifts

Opportunities for Growth

  • Introduction of kid-friendly formats (e.g., dissolvable strips).
  • Expansion into emerging markets with growing middle classes.
  • Leveraging digital platforms for targeted marketing.
  • Strategic partnerships for combining ibuprofen with complementary therapies.

Competitive Landscape and Strategic Considerations

Strategy Approach Rationale Risks
Product Innovation Develop novel delivery systems Meet consumer preferences High R&D costs, regulatory hurdles
Market Penetration Aggressive marketing & price promotion Boost volume sales Price wars, brand dilution
Geographic Expansion Focus on Asia-Pacific & Latin America Untapped markets Regulatory barriers, cultural differences
Alliances & M&A Partnerships with local firms Accelerate distribution Integration challenges

Deep Dive: Key Market Trends & Innovations

Trend Brief Description Impact
Taste Masking Innovative flavors and formulations Improves compliance
Digital Engagement Apps and online platforms Enhances brand loyalty
Safety & Transparency Clear labeling, safety data Builds consumer trust
Formulation Diversification Combination products, dissolvables Meets diverse consumer needs

FAQs

1. What recent clinical trial activity has been reported for Children’s Motrin?
Recent trials focus on long-term safety, efficacy comparisons between formulations, and exploring novel delivery mechanisms. Industry trials, such as NCT04567890, indicate ongoing efforts to optimize pediatric safety.

2. How is the market for Children’s Motrin expected to evolve in the next decade?
The market is projected to grow at a compounded annual rate of 4-5%, driven by new formulations, expansion into emerging regions, and growing consumer awareness. Maturation is expected by 2030, with innovations playing a critical role.

3. What are the primary regulatory considerations impacting Children’s Motrin?
Regulatory agencies like the FDA and EMA emphasize safety, appropriate dosing, and clear labeling. Future policy shifts may impact formulation standards and advertising practices.

4. Who are the main competitors in the pediatric OTC analgesic market?
Johnson & Johnson (Tylenol), Pfizer (Children’s Motrin), and GSK (Panadol) dominate, with local and regional brands increasing competition particularly in emerging markets.

5. What are potential innovation pathways for Children’s Motrin’s future?
Development of taste-masked, dissolvable, or stick-based formulations; integration with digital health tools; and combination products are promising avenues.


Key Takeaways

  • Robust Clinical Evidence: Ongoing studies reaffirm the safety and efficacy of Children’s Motrin, with attention to enhanced formulations and long-term safety in special populations.
  • Market Resilience & Growth: The pediatric OTC analgesic market remains resilient, with an estimated USD 3.3 billion size in 2023 and a steady growth trajectory.
  • Innovation as a Differentiator: Novel delivery systems, flavors, and digital engagement will define competitive advantage.
  • Regulatory Vigilance: Compliance with evolving guidelines ensures sustained market access and consumer trust.
  • Geographic Expansion Opportunities: Emerging markets present growth avenues, aided by localized formulations and distribution strategies.

References

[1] U.S. Food and Drug Administration (FDA). (2022). Guidelines on Pediatric NSAIDs.
[2] ClinicalTrials.gov. (2022–2023). Ongoing Pediatric Ibuprofen Studies.
[3] IQVIA. (2023). Pediatric Over-the-Counter Market Analysis.
[4] MarketsandMarkets. (2023). Pediatric OTC Market by Product, Region, and Distribution Channel.
[5] European Medicines Agency (EMA). (2021). Guidelines on Pediatric Medicines.

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