Topical Magnesium Sulfate Versus Peritonsillar Bupivacaine for Post-Tonsillectomy Pain Relief in Children

NCT07760207 | Not Yet Recruiting Phase 4

• 1 other identifier: Topical MgSO4 vs Bupivacaine
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Tonsillectomy (tonsil removal) is a very common surgery for children, but it often causes significant throat and ear pain afterward. Doctors usually inject a numbing medicine, such as bupivacaine, into the area around the tonsils to help control this pain. However, these injections require needles, which can cause swelling, distort tissue, and slightly increase the risk of bleeding or infection, and the pain relief typically only lasts for about 4 to 6 hours. This study is investigating a needle-free alternative to see if it provides effective pain relief. The researchers are testing a medication called magnesium sulfate, which blocks certain pain receptors and can be applied directly to the surgical site using a soaked gauze pad instead of a needle injection. The main goal of this clinical trial is to compare how well topical magnesium sulfate relieves pain compared to standard bupivacaine injections in children undergoing tonsillectomy. The study will include 40 children between the ages of 8 and 15 years old. During the surgery, while under general anesthesia, half of the children will receive the topical magnesium sulfate pad applied to the surgical area for 5 minutes, and the other half will receive the standard bupivacaine injection. After the surgery, researchers will measure the children's pain levels using visual pain scales featuring faces and numbers. They will also track how much extra pain medication the children need, how well their surgical wounds heal, and if they experience any adverse effects.

Conditions

Post-tonsillectomy Pain; Tonsillectomy; Postoperative Pain; Tonsillectomy Distress Syndrome; Odynophagia

Keywords

Tonsillectomy; Magnesium Sulfate; Bupivacaine; Analgesia; Pediatric; Peritonsillar Infiltration

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity Assessed by the Wong-Baker FACES Pain Rating Scale

  The Wong-Baker FACES Pain Rating Scale is a visual assessment tool that features a series of six cartoon faces showing different emotional expressions to help pediatric patients communicate their pain levels. The scale ranges from a minimum score of 0, which corresponds to a happy, smiling face meaning "No Hurt," to a maximum score of 10, which corresponds to a sad, crying face meaning "Hurts Worst". Higher scores on this scale indicate greater pain intensity, reflecting a worse patient outcome.

  At 24 hours postoperatively

Study Arms (2)

Group A: Topical Magnesium Sulfate

EXPERIMENTAL

Participants in this group will have a sterile gauze soaked in 5 mL of 20% magnesium sulfate (2 mg/kg) packed into the tonsillar fossa for 5 minutes post-hemostasis.

Drug: Magnesium Sulfate

Group B: Peritonsillar Bupivacaine

ACTIVE COMPARATOR

Participants in this group will receive an injection of 2 mL of 0.25% bupivacaine directly into the peritonsillar space, specifically at the superior, middle, and inferior poles.

Drug: Bupivacaine

Interventions

Magnesium Sulfate DRUG

Topical application via a sterile gauze soaked in 5 mL of 20% magnesium sulfate (2mg/kg) packed into the fossa for 5 minutes post-hemostasis.

Group A: Topical Magnesium Sulfate

Bupivacaine DRUG

Peritonsillar infiltration involving the injection of 2 mL of 0.25% bupivacaine into the superior, middle, and inferior poles of the peritonsillar space.

Group B: Peritonsillar Bupivacaine

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients aged 8-15 years undergoing elective tonsillectomy.

You may not qualify if:

• Patients younger than 8 years or older than 15 years.
• Known allergy to magnesium sulfate or bupivacaine.
• Pre-existing neurological disorders (for example, neuromuscular diseases, epilepsy) that could affect pain perception or magnesium metabolism.
• Pre-existing cognitive impairment or developmental delay affecting pain assessment.
• Chronic pain syndromes or regular use of analgesics.
• Coagulopathy or bleeding disorders.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Magnesium Sulfate; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Otolaryngology

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08