Comparsion of Intravenous Injection of Magnesium Sulfate and Lidocaine Effectiveness on the Prevention of Laryngospasm and Analgesic Requirement in Tonsillectomy

NCT ID: NCT06761547

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-03-01

Brief Summary

Tonsillectomy is one of the most common surgeries in children which is associated with many morbidities such as postoperative pain, nausea, vomiting, bleeding and laryngospasm .

Laryngospasm is a dangerous complication of tonsillectomy that occurs following tracheal extubation It is characterized by a strong, involuntary contraction of the laryngeal muscles, it's frequency in children is higher than adults due to their narrow upper airways that can be blocked following edema and inflammation The incidence of laryngospasm is 17 per 1000 children younger than nine years old, which increases to 96 per 1000 children with upper respiratory tract infections There are several ways to prevent this complication, including complete haemostasis during surgery, gentle suctioning of the oropharynx before extubation and the use of drugs as intravenous or topical lidocaine, propofol and etc .

Postoperative pain control after the tonsillectomy has a very important role in recovery time, hospitalization duration, bleeding, nausea and vomiting.

Lidocaine is an antiarrhythmic drug and its main mechanism of action is blocking voltage-gated Na+ channels that inhibit the activity of the upper laryngeal nerve and reduces the long-term blockage of the glottis .

Magnesium sulphate has a calcium antagonist property, which provides muscle relaxation and increases flaccidity. It also has an antagonistic action on sodium channels and N-methyl-D-aspartate receptors and reduces the release of substance P, which decreases the airway reactivity and stress responses .

Therefore we decided to compare the effect of intravenous injection of magnesium sulfate and lidocaine on the prevention of laryngospasm occurrence, and analgesic requirement in tonsillectomy the goal of the study Comparing the effectiveness of magnesium sulfate and lidocaine in prevention of post tonsillectomy complication .

Detailed Description

Tonsillectomy is one of the most common surgeries in children which is associated with many morbidities such as postoperative pain, nausea, vomiting, bleeding and laryngospasm .

Laryngospasm is a dangerous complication of tonsillectomy that occurs following tracheal extubation It is characterized by a strong, involuntary contraction of the laryngeal muscles, it's frequency in children is higher than adults due to their narrow upper airways that can be blocked following edema and inflammation The incidence of laryngospasm is 17 per 1000 children younger than nine years old, which increases to 96 per 1000 children with upper respiratory tract infections There are several ways to prevent this complication, including complete haemostasis during surgery, gentle suctioning of the oropharynx before extubation and the use of drugs as intravenous or topical lidocaine, propofol and etc .

Postoperative pain control after the tonsillectomy has a very important role in recovery time, hospitalization duration, bleeding, nausea and vomiting.

Lidocaine is an antiarrhythmic drug and its main mechanism of action is blocking voltage-gated Na+ channels that inhibit the activity of the upper laryngeal nerve and reduces the long-term blockage of the glottis .

Magnesium sulphate has a calcium antagonist property, which provides muscle relaxation and increases flaccidity. It also has an antagonistic action on sodium channels and N-methyl-D-aspartate receptors and reduces the release of substance P, which decreases the airway reactivity and stress responses .

Therefore we decided to compare the effect of intravenous injection of magnesium sulfate and lidocaine on the prevention of laryngospasm occurrence, and analgesic requirement in tonsillectomy

Conditions

Tonsillectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

patients will take magnsium sulfate 15 mg/kg on 50 ml saline

Group Type: ACTIVE_COMPARATOR

magnsium sulfate

Intervention Type: DRUG

patients will take magnsium sulfate 15 mg/kg IV

Saline

Intervention Type: DRUG

50 ml saline IV

Group B

Patients will take lidocaine2% 1 mg/kg on 50 ml saline

Group Type: ACTIVE_COMPARATOR

Lidocaine (drug)

Intervention Type: DRUG

patients will take lidocaine2% 1 mg/kg

Saline

Intervention Type: DRUG

50 ml saline IV

Group c

patients will take 50 ml saline only

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

50 ml saline IV

Interventions

magnsium sulfate

patients will take magnsium sulfate 15 mg/kg IV

Intervention Type: DRUG

Lidocaine (drug)

patients will take lidocaine2% 1 mg/kg

Intervention Type: DRUG

Saline

50 ml saline IV

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• -ASA physical status I-II.
• Both sexes.
• Age: children 3-14years old.
• patients subjected for tonsillectomy or adeno-tonsillectomy surgery with parental consent for participation in the study.

Exclusion Criteria

• - patients who refused to participate in this study.
• History of allergic response to magnesium sulfate and liodcaine .
• the Prescence of cardiovascular, respiratory and kidney diseases.
• A recent history of upper respiratory tract infection and febrile illness.
• History of mythenia gravis.
• patients subjected for adeno-tonsillectomy with myringotomy

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Martina Monwar Shawky

residant doctor at Assiut university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Martina Monwar Shawky, residant doctor

Role: CONTACT

Martina.16266180@med.aun.eg

+201282250951

References

Stalfors J, Ericsson E, Hemlin C, Hultcrantz E, Mansson I, Roos K, Hessen Soderman AC. Tonsil surgery efficiently relieves symptoms: analysis of 54 696 patients in the National Tonsil Surgery Register in Sweden. Acta Otolaryngol. 2012 May;132(5):533-9. doi: 10.3109/00016489.2011.644252. Epub 2012 Jan 11.

Reference Type: BACKGROUND

PMID: 22235871 (View on PubMed)

Other Identifiers

Tonsillectomy operation

Identifier Type: -

Identifier Source: org_study_id