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

7 de agosto de 2026 actualizado por: Abd El-Rahman Ahmed Aboulwafa, Assiut University

Topical Magnesium Sulfate Versus Peritonsillar Bupivacaine Infiltration for Post-Tonsillectomy Analgesia: A Prospective, Randomized Trial

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Postoperative pain following tonsillectomy is a primary cause of morbidity in the pediatric population, frequently leading to "tonsillectomy distress syndrome," which is characterized by severe odynophagia, referred otalgia, and psychological distress. The underlying pathophysiology of this pain is complex, involving both mechanical trauma to the pharyngeal constrictor muscles and the chemical irritation of the vagus and glossopharyngeal nerve endings.

While perioperative analgesia is traditionally managed with local anesthetic infiltration, such as bupivacaine, its analgesic efficacy is typically limited to a short duration of 4 to 6 hours. Furthermore, the physical act of needle infiltration can induce tissue edema, distort surgical planes, and potentially elevate the risk of postoperative complications, including infection and hemorrhage.

Recent advancements in pain management have highlighted the role of N-methyl-D-aspartate (NMDA) receptors in peripheral tissues, presenting new avenues for non-invasive analgesia. Magnesium sulfate serves as an NMDA receptor antagonist by blocking its calcium channel in a voltage-dependent manner. This trial investigates whether applying magnesium sulfate topically to the tonsillar fossa can provide effective postoperative analgesia without the inherent risks associated with needle infiltration.

To ensure procedural standardization across the study, all tonsillectomies in this prospective, randomized trial will be performed utilizing a cold dissection technique under general anesthesia. Postoperatively, patients will be systematically evaluated to assess pain intensity, mucosal healing via a 5-point fibrin and epithelialization grading scale, and the overall requirement for rescue analgesics.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • Fase 4

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Group A: Topical Magnesium Sulfate
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.
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.
Comparador activo: Group B: Peritonsillar Bupivacaine
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.
Peritonsillar infiltration involving the injection of 2 mL of 0.25% bupivacaine into the superior, middle, and inferior poles of the peritonsillar space.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative Pain Intensity Assessed by the Wong-Baker FACES Pain Rating Scale
Periodo de tiempo: At 24 hours postoperatively
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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de septiembre de 2027

Finalización del estudio (Estimado)

1 de octubre de 2027

Fechas de registro del estudio

Enviado por primera vez

7 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

7 de agosto de 2026

Publicado por primera vez (Actual)

12 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Topical MgSO4 vs Bupivacaine

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .