HPLC Confirms Dosing in Pain-Relief Lollipop

Pain after tonsil and adenoid removal is one of the biggest problems children face when recovering at home. A big part of the issue is that regular liquid or pill pain medicines taste bad and are hard to swallow when a child's throat is sore, so the patient often do not take them properly. In response to this, a research team from the University Hospital of Caracas (Venezuela), looked at creating and testing a new kind of medicated lollipop made from a gelatin and carboxymethylcellulose blend, containing the pain reliever diclofenac potassium. It comes in three different strengths (15 mg, 20 mg, and 30 mg) to suit different children's weights. The development portion of the study focused on fine-tuning the lollipop recipe through repeated testing, then checking its basic properties, such as acidity, moisture level, thickness, and making sure the medicine was evenly distributed throughout (measured using high-performance liquid chromatography [HPLC]). The team also tested the lollipop for cleanliness/safety from germs, following official U.S. pharmacy quality guidelines. A paper based on their efforts was published in the journal Cureus.¹

Why Does Post-Surgery Pain After Tonsil/Adenoid Removal Matter, and What Happens if It Is Not Managed Well?

Removing the tonsils and adenoids is one of the most common planned surgeries done on children, making up a large chunk of all childhood operations worldwide. While it's generally considered safe and most patients go home the same day, the pain afterward is often not taken seriously enough, even though it can seriously affect a child's recovery. This pain comes from several things happening at once: the tissue itself is injured during surgery, the throat muscles can spasm as a reflex, and the body's inflammation response kicks in around the wound. Together, these cause real difficulty and pain when swallowing, which usually lasts anywhere from 1 to 10 days after surgery. When this pain is not well controlled, the effects go beyond just feeling uncomfortable. Children may eat and drink less, which can lead to dehydration and weight loss. Poor sleep can slow down healing. In some cases, the pain gets bad enough that families end up back at the doctor's office or hospital when it could have been avoided.^2,3

Why Would a Lollipop Format Make Sense to Deliver Medicine to Children?

Delivering medicine through candy-like products that dissolve in the mouth is a smart and practical way to solve this problem of children not taking their medicine properly. The inside of the mouth has many blood vessels close to the surface, so some of the medicine can be absorbed directly there and get into the bloodstream faster, skipping the usual delay caused by the liver processing it first. Any medicine that is not absorbed this way just gets swallowed along with saliva and gets absorbed normally through the stomach and gut, just like a regular pill would be. This approach isn't new or unproven; it has already been used successfully with a fentanyl-based lollipop-style medicine that dissolves in the cheek to treat pain in children during medical procedures. Studies on that product showed it worked quickly and effectively and entered the bloodstream noticeably faster than if the same drug had been given as a regular swallowed tablet.^4,5

“Medicated lollipops,” write the authors of the paper,¹ “extend this principle to a format that is inherently appealing to young children: the familiar confectionery vehicle encourages voluntary acceptance and sustained oral retention—the two prerequisites for effective transmucosal delivery—without triggering the anxiety that accompanies tablet or syrup administration.”

Was the Lollipop Effective at Relieving Pain, Safe, and Well-Tolerated by Children After Tonsil/Adenoid Surgery?

The researchers report that their final version of the lollipop turned out to have a slightly acidic level close to neutral (average pH 5.67), a smooth and consistent texture, and laboratory tests confirmed the medicine amount was almost exactly right (within 100.7% to 102.9% of what the label said) for all three strengths. It also passed all cleanliness/safety checks.¹

The second part of the study tested the lollipop in real patients: 50 children between 4 and 12 years old who were otherwise healthy or had only mild, well-controlled health conditions (based on a standard anesthesia safety rating system). The children were given one lollipop every 8 hours for a full day after surgery. Before and one hour after each dose, the children’s pain levels were checked using simple pain-rating tools (either a sliding scale or a chart of facial expressions ranging from happy to very upset). The results showed that pain levels steadily went down after each dose across all three strengths, and by the third check after surgery, most children reported little to no pain at all. Most test subjects (83%) said they liked the taste and texture of the lollipop. Importantly, no side effects or safety issues came up during the entire study.¹

“These findings,” write the authors of the paper,¹ “establish the pharmaceutical viability and preliminary clinical promise of this formulation as a child-friendly analgesic vehicle and provide a compelling rationale for a powered randomized controlled trial with pharmacokinetic characterization.”

References

1. Veraza, J. A.; Veraza, S. A.; Almeida, M. Z. Development and Preliminary Clinical Evaluation of a Novel Gelatin-Based Diclofenac Potassium-Medicated Lollipop for Post-adenotonsillectomy Pain Management in Children: A Prospective Pilot Study. Cureus 2026, 18 (7), e113456. DOI: 10.7759/cureus.113456
2. Mitchell, R. B.; Archer, S. M.; Ishman, S. L. et al. Clinical Practice Guideline: Tonsillectomy in Children (Update). Otolaryngol Head Neck Surg. 2019,160 (1_suppl), S1-S42. DOI: 10.1177/0194599818801757
3. Bhattacharyya, N. Ambulatory Pediatric Otolaryngologic Procedures in the United States: Characteristics and Perioperative Safety. Laryngoscope 2010, 120 (4), 821-825. DOI: 10.1002/lary.20852
4. Romero, M.; Herrero, M.; Torres, D. et al. Postoperative Pain and Swelling Treatment Protocol. A Rational Approach [Article in Spanish]. RCOE 2006, 11, 205-15. https://scielo.isciii.es/pdf/rcoe/v11n2/205_215.pdf
5. Oztekin, S.; Hepağuşlar, H.; Kar, A. A. et al. Preemptive Diclofenac Reduces Morphine Use After Remifentanil-Based Anaesthesia for Tonsillectomy. Paediatr Anaesth. 2002, 12, 694-699. 10.1046/j.1460-9592.2002.00950.x