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

Sponsor
Assiut University
Study ID
NCT07760207
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
8 Years - 15 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Aug 12, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: 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.

Primary Outcome Measure

Postoperative Pain Intensity Assessed by the Wong-Baker FACES Pain Rating Scale [ Time Frame: At 24 hours postoperatively ]

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