An interventional study of Bupivacaine hydrogen chloride (HCl) %0.125 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injection and Bupivacaine hydrogen chloride (HCl) %0.25 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injection in Pain, Postoperative, sponsored by Istanbul University. Completed at 1 site in Turkey (Türkiye). Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Istanbul University · Not applicable, Interventional, and Supportive care
Tonsilloadenoidectomy operations in pediatric patients cause local pain. Especially, in order to reduce the need for narcotic painkillers, to ensure patient compliance and well-being, and to provide better quality pain management regional pain prevention methods, which are included in the guidelines, are applied to these patients. One of these methods is glossopharyngeal nerve block. This block is the blocks that the investigators routinely apply to patients in different uses for the purpose of pain management before/after adenotonsillectomy operations in the clinic. The investigators plan to apply the glossopharyngeal nerve card that the investigators will make in different doses and follow the patient's pain and stomach volume after the surgery.
In this study, a group of patients who will undergo adenotonsillectomy surgery will be performed glossopharyngeal nerve block with 0,2 milliliter/kilogram (ml/kg) %0.125 bupivacaine bilaterally; the other group will be performed glossopharyngeal nerve block with 0,2 milliliter/kilogram %0.25 bupivacaine bilaterally. Postoperatively, patient's pain level, stomach volume, possible undesirable results, hospital stay, and satisfaction level will be monitored and recorded. The results will be compared. After reading and signing the informed consent form, the block will be applied under general anesthesia in the operating room with monitorization, and then the operation will be performed under general anesthesia. Post-operative follow-up will be done.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 120 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Istanbul University is the lead sponsor of 507 studies on the registry; 80 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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In this group, glossopharyngeal block will be performed with 0.2 milliliter/kilogram (ml/kg) of %0.125 bupivacaine bilaterally
Drug: Bupivacaine hydrogen chloride (HCl) %0.125 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injection
In this group, glossopharyngeal block will be performed with 0.2 milliliter/kilogram (ml/kg) of %0.25 bupivacaine bilaterally
Drug: Bupivacaine hydrogen chloride (HCl) %0.25 in 0,2 milliliter/kilogram (ml/kg)+ 0,2 milliliter/kilogram (ml/kg) injection
Drug page: Bupivacaine
In this group, glossopharyngeal nerve block will be performed with 0,2 milliliter/kilogram (ml/kg) +0,2 milliliter/kilogram (ml/kg) %0.125 bupivacaine for each block site
Also known as: marcaine
In this group, glossopharyngeal nerve block will be performed with 0,2 milliliter/kilogram (ml/kg) +0,2 milliliter/kilogram (ml/kg) %0.25 bupivacaine for each block site
Also known as: Bupivacaine hydrogen chloride (HCl) %0.125 in 0,2 ml/kg+ 0,2 ml/kg injection
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score at Rest at 30 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
Time frame: 30 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score During Swallowing at 30 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
Time frame: 30 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score at Rest at 60 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
Time frame: 60 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score During Swallowing at 60 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
Time frame: 60 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score at Rest at 120 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
Time frame: 120 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score During Swallowing at 120 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
Time frame: 120 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score at Rest at 240 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
Time frame: 240 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) Pain Score During Swallowing at 240 Minutes Postoperatively
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used to assess pain. The total score ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain intensity. Pain scores are assessed separately at rest and during swallowing.
Time frame: 240 Minutes Postoperatively
The gag reflex
The gag reflex is assessed in the recovery room using a 4-point scale ranging from 0 to 3, with 0 indicating no gag reflex and 3 indicating a severe gag reflex reaction. Higher scores indicate a more pronounced gag reflex response.
Time frame: 30 Minutes Postoperatively
Gastric Volume Assessed by Ultrasound
Gastric volume is assessed and calculated using ultrasonography.
Time frame: 30 Minutes Postoperatively
Gastric Volume Assessed by Ultrasound
Gastric volume is assessed and calculated using ultrasonography.
Time frame: 60 Minutes Postoperatively
Gastric Volume Assessed by Ultrasound
Gastric volume is assessed and calculated using ultrasonography.
Time frame: 120 Minutes Postoperatively
Gastric Volume Assessed by Ultrasound
Gastric volume is assessed and calculated using ultrasonography.
Time frame: 240 Minutes Postoperatively
Postoperative Complications
The occurrence of the following postoperative complications are assessed: nausea, vomiting, local anesthetic systemic toxicity, bradycardia, choking sensation, dry mouth, nasal congestion, and hoarseness. Each event is recorded as present or absent.
Time frame: From the end of the procedure through 24 hours postoperatively
Time to First Postoperative Feeding
Time from the end of the procedure to the patient's first postoperative feeding
Time frame: From the end of the procedure through 24 hours postoperatively
Time to First Opioid Analgesic Requirement
Time from the end of the procedure to the first requirement for opioid analgesic medication during the postoperative period
Time frame: From the end of the procedure through 24 hours postoperatively
Parental Satisfaction
Parental satisfaction is assessed using a 5-point scale ranging from 1 to 5, with 5 indicating very high satisfaction.
Time frame: Before hospital discharge
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Studies of the drug tested here: Bupivacaine