A Phase 4 interventional study of Magnesium Sulfate and Bupivacaine in Post-tonsillectomy Pain, Tonsillectomy and Postoperative Pain, sponsored by Assiut University. Not yet recruiting. Open to participants aged 8 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Assiut University · Phase 4, Interventional, and Treatment
Among 43 studies testing Magnesium Sulfate in Pain, Postoperative — 7 open to participants now, 7 under way, none of them phase 3. Magnesium Sulfate · Pain, Postoperative.
Among the 43 studies testing Magnesium Sulfate in Pain, Postoperative, this one is the 39th largest by planned enrollment, is one of 7 that started in 2026, is one of 16 in phase 4, and was the 37th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 40 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →7 of the 43 studies testing Magnesium Sulfate in Pain, Postoperative are open now, in 2 countries. Each count lists the studies.
Magnesium Sulfate: first FDA approval 1981 (TIS-U-SOL IN PLASTIC CONTAINER). What it is approved for, and how studies give it, is on its page →
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 8 Years to 15 Years · all sexes · no healthy volunteers.
The full table on the hub →43 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 7 started in 2026.
Median enrollment 70 across the 43 interventional studies. Of the 25 that completed or were terminated, 4 (16%) have results posted.
None of the 43 has an industry lead sponsor. The 10 most frequent:
Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
108 studies in Pain, Postoperative by Assiut University: 30 open now, 31 under way, 5 of them phase 3. Of 48 finished, 0 (0%) have results posted.
Among the 108 studies in Pain, Postoperative by Assiut University, this one is the 94th largest by planned enrollment of the 107 interventional ones, is one of 17 that started in 2026, is one of 10 in phase 4, reaches primary completion later than 16 of the 30 other live ones, and was the 97th registered.
Assiut University’s Pain, Postoperative studies by the year they started, since 2013.
4 of the studies testing Magnesium Sulfate in Pain, Postoperative that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07773220Khyber Teaching HospitalMagnesium Sulphate Versus Dexamethasone With TAP Block for Post-Cesarean Analgesia | 2027-02-28 |
| NCT07803601Ain Shams UniversityEffect of Intravenous Magnesium on Postoperative Systemic Inflammatory Response in Patients Undergoing Colorectal Cancer Surgery | 2027-03-01 |
| NCT07840183Northwestern UniversityEpidural Analgesia Versus Opioid-sparing Analgesia for Open Ventral Hernia Repair With Transversus Abdominis Release | 2027-09 |
| NCT07760207Assiut UniversityTopical Magnesium Sulfate Versus Peritonsillar Bupivacaine for Post-Tonsillectomy Pain Relief in Children | 2027-09 |
Among the 43 studies testing Magnesium Sulfate in Pain, Postoperative, from their registry updates:
Among Assiut University’s 108 in Pain, Postoperative:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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.
Peritonsillar infiltration involving the injection of 2 mL of 0.25% bupivacaine into the superior, middle, and inferior poles of the peritonsillar space.
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.
Time frame: At 24 hours postoperatively
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 531 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's planned 12 months is below that.
Counting every sponsor, half of 541 studies reached it within 16 months; a quarter within 8 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Magnesium Sulfate