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

A

Assiut University

Status and phase

Not yet enrolling
Phase 3

Conditions

Tonsillectomy

Treatments

Drug: magnsium sulfate
Drug: Lidocaine (drug)
Drug: Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT06761547
Tonsillectomy operation

Details and patient eligibility

About

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 .

Full 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

Enrollment

90 estimated patients

Sex

All

Ages

3 to 14 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 3 patient groups, including a placebo group

Group A
Active Comparator group
Description:
patients will take magnsium sulfate 15 mg/kg on 50 ml saline
Treatment:
Drug: Saline
Drug: magnsium sulfate
Group B
Active Comparator group
Description:
Patients will take lidocaine2% 1 mg/kg on 50 ml saline
Treatment:
Drug: Saline
Drug: Lidocaine (drug)
Group c
Placebo Comparator group
Description:
patients will take 50 ml saline only
Treatment:
Drug: Saline

Trial contacts and locations

0

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Central trial contact

Martina Monwar Shawky, residant doctor

Data sourced from clinicaltrials.gov

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