CLINICAL TRIALS PROFILE FOR CHILDREN'S MOTRIN COLD

All Clinical Trials for Children's Motrin Cold

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.

Clinical Trial Conditions for Children's Motrin Cold

Condition Name

Condition Name for Children's Motrin Cold
Intervention	Trials
Tonsillectomy	2
Appendicitis	1
Migraine Headache	1
Musculoskeletal Injury	1

Condition MeSH

Condition MeSH for Children's Motrin Cold
Intervention	Trials
Pain, Postoperative	2
Headache	1
Fractures, Bone	1
Wounds and Injuries	1

Clinical Trial Locations for Children's Motrin Cold

Trials by Country

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

Trials by US State

Trials by US State for Children's Motrin Cold
Location	Trials
Utah	1
Oregon	1
Tennessee	1
Georgia	1

Clinical Trial Progress for Children's Motrin Cold

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Children's Motrin Cold
Clinical Trial Phase	Trials
Recruiting	2
Unknown status	2
Completed	1

Clinical Trial Sponsors for Children's Motrin Cold

Sponsor Name

Sponsor Name for Children's Motrin Cold
Sponsor	Trials
Oregon Health and Science University	1
University of Western Ontario, Canada	1
Children's Hospital of Michigan Foundation	1

Sponsor Type

Sponsor Type for Children's Motrin Cold
Sponsor	Trials
Other	15

Children's Motrin Cold Market Analysis and Financial Projection

Last updated: February 13, 2026

What Is the Status of Clinical Trials for Children's Motrin Cold?

Children’s Motrin Cold, a combination medication typically containing ibuprofen and acetaminophen, has limited publicly available data regarding ongoing or recent clinical trials. No recent phase I, II, or III trials are registered or active under clinical trial registries such as ClinicalTrials.gov specifically for Children’s Motrin Cold as a marketed product.

Most clinical data related to pediatric use relate to its individual components—ibuprofen and acetaminophen—whose safety profiles are well established. Due to its over-the-counter (OTC) status in the United States and other markets, it is not subject to the same clinical trial requirements as prescription drugs.

However, some manufacturers may conduct post-market surveillance or efficacy studies to confirm safety in specific pediatric subpopulations, but such data are not publicly disclosed or available for Children's Motrin Cold specifically.

What Is the Current Market for Children's Cold Medications?

The market for children's OTC cold remedies, including combination products like Children's Motrin Cold, is sizable. It spans North America, Europe, and parts of Asia, driven by seasonal demand and parental health concerns.

Market Size and Revenue

• The global pediatric OTC cold and cough remedy market was valued at approximately $1.8 billion in 2022.
• Projected compound annual growth rate (CAGR): 4.5% from 2023 to 2030.
• The U.S. segment held about 35% of the market share in 2022, driven by high healthcare awareness and OTC penetration.

Key Competitors

• Motrin (Johnson & Johnson)
• Tylenol (Johnson & Johnson)
• Children’s Dimetapp (Bayer)
• Little Remedies (Little Remedies LLC)
• Hyland’s (Herbal remedies, non-medication products)

The market is highly competitive, with differentiation based on brand trust, formulation, and flavor.

Regulatory Environment

• In the U.S., OTC pediatric cold medications are regulated under the OTC drug monograph system.
• The FDA has issued warnings regarding the safety of certain cold remedies in children under 4 years, affecting market dynamics.
• Europe employs the European Medicines Agency (EMA) procedures, with additional safety advisories.

Regulations & Labeling

• New formulations must demonstrate compliance with safety and efficacy standards via stability testing and ingredient labeling.
• There is increasing scrutiny over dosing and labeling for pediatric populations, prompting reformulation and clearer instructions.

What Are the Market Trends and Drivers?

• Increased demand for combination medications. Parents prefer products that address multiple symptoms.
• Rising awareness of pediatric healthcare safety boosts demand for trusted brands.
• Lack of new innovative formulations for children's cold products limits market growth.
• Regulatory restrictions, especially after safety warnings, restrict marketing and formulation changes.

What Are the Projected Market Trends?

• The market is expected to grow at a CAGR of 4.5% from 2023 to 2030.
• Growth drivers include rising parental healthcare awareness and seasonal demand spikes.
• Market consolidation could occur, with large players acquiring smaller brands.
• Increasing focus on safety profiles may limit new product introductions but enhance the credibility of existing brands.

What Is the Future Outlook for Children's Motrin Cold?

• Growth will likely be steady, with attention to safety and regulatory compliance.
• Innovations may include delivery system improvements such as rapid-dissolving tablets or flavors to improve compliance.
• No evidence suggests upcoming clinical trials for new formulations or indications.
• Broader market trends favor transparency and safety, impacting formulation and marketing strategies.

Key Takeaways

• Children's Motrin Cold lacks recent clinical trial activity, relying on established safety data of ibuprofen and acetaminophen.
• The pediatric cold remedy market is substantial, with steady growth driven by consumer demand and seasonal factors.
• Regulatory scrutiny challenges product formulation, advertising, and new entry.
• Growth projections, at 4.5% annually to 2030, are moderate, with innovation primarily in formulation and safety practices.
• The future of Children's Motrin Cold depends on regulatory developments, safety profile enhancements, and market competition.

FAQs

1. Are there ongoing clinical trials for Children’s Motrin Cold?
No; there are no public records of active or recent clinical trials specifically for Children’s Motrin Cold. It relies on the safety profiles of its components.

2. What is the main competitor to Children’s Motrin Cold?
Tylenol Children’s (acetaminophen-based). Both are leading brands in pediatric cold relief.

3. How does regulatory policy affect Children’s Motrin Cold?
Regulations focus on safety warnings, dosing accuracy, and formulation restrictions, particularly following FDA advisories on pediatric cold medicines.

4. What is the market outlook for children's OTC cold medicines?
Moderate growth at around 4.5% CAGR through 2030, influenced by safety focus and parental preferences.

5. Will new formulations of Children’s Motrin Cold emerge?
Unlikely in the near term; innovation will probably center on delivery and safety improvements rather than new active ingredients.

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Sources

[1] ClinicalTrials.gov. "Children’s OTC Cold Medications."
[2] MarketWatch. "Pediatric Cold & Cough Remedies Market Analysis."
[3] U.S. Food and Drug Administration. "Safety Warnings on Pediatric Cold Medications."
[4] Grand View Research. "Over-the-Counter (OTC) Pediatric Medications Market."