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Ketamine Versus Magnesium as Analgesic Adjuvants in Pediatric Adenotonsillectomy

Primary Purpose

Post Operative Pain, Acute

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ketamine hydrochloride
Magnesium sulfate
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Operative Pain, Acute

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Both genders.
  2. American society of anesthesiologists (ASA) physical status class I and ll.
  3. Patients undergoing adeno-tonsillectomy.

Exclusion Criteria:

  1. Inability to provide an informed consent.
  2. Patients with suspected difficult airway.
  3. History of allergy to ketamine or magnesium.
  4. Metabolic and endocrine disorders.
  5. Growth developmental, and motor-mental retardation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Ketamine group

    Magnesium group

    Arm Description

    After preoperative assessment, participants will receive IM midazolam (0.1 mg/kg) and atropine (0.02 mg/kg) 30 min. before surgery as premedication. Inhalation induction of GA will be done using 8% sevoflurane in 100% oxygen. After insertion of a peripheral IV cannula, IV fentanyl 1 mcg/kg and atracurium 0.5 mg/kg will be given. Direct laryngoscopy will be attempted to insert an age-appropriate cuffed ETT. Patients will be maintained on controlled mechanical ventilation with a mixture of isoflurane in 60% oxygen in air, using a tidal volume of 8cc/kg and a frequency of 16-20 cycle/min. to maintain an ETCO2 35-40 mmHg and to keep an ET isoflurane concentration of 1.5-2%. All patients will receive 10 ml/kg of IV Ringer's solution in the operating room. A single dose of paracetamol 15 mg/kg IV drip will be administered for all patients once they arrive at the PACU. Patients will receive IV ketamine hydrochloride in a dose of 0.5 mg/kg.

    After preoperative assessment, participants will receive IM midazolam (0.1 mg/kg) and atropine (0.02 mg/kg) 30 min. before surgery as premedication. Inhalation induction of GA will be done using 8% sevoflurane in 100% oxygen. After insertion of a peripheral IV cannula, IV fentanyl 1 mcg/kg and atracurium 0.5 mg/kg will be given. Direct laryngoscopy will be attempted to insert an age-appropriate cuffed ETT. Patients will be maintained on controlled mechanical ventilation with a mixture of isoflurane in 60% oxygen in air, using a tidal volume of 8cc/kg and a frequency of 16-20 cycle/min. to maintain an ETCO2 35-40 mmHg and to keep an ET isoflurane concentration of 1.5-2%. All patients will receive 10 ml/kg of IV Ringer's solution in the operating room. A single dose of paracetamol 15 mg/kg IV drip will be administered for all patients once they arrive at the PACU. Patients will receive IV magnesium sulphate in a dose of 40 mg/kg.

    Outcomes

    Primary Outcome Measures

    The postoperative pain score
    The postoperative pain score after adeno-tonsillectomy using modified Children's Hospital Eastern Ontario Pain Scale (CHEOPS). It is a behavioral scale that includes 6 categories (each has a score from 0 to 2): cry, facial, verbal, torso, legs and touch (with a total score range from 0 to 12). Higher scores mean worse outcome (higher pain intensity).

    Secondary Outcome Measures

    Extubation time
    The duration between the end of anesthesia and extubation
    Recovery time
    the period in minutes from extubation until patient reaches a score of 9 or higher according to modified Aldrete score, when the patients will be ready to transfer to the ward
    Heart rate
    Preoperative, intraoperative and postoperative heart rate (beats per minute)
    Mean arterial blood pressure
    Preoperative, intraoperative and postoperative mean arterial blood pressure (in mmHg)
    Postoperative nausea and vomiting in the PACU
    The incidence of postoperative nausea and vomiting in the PACU (yes or no)

    Full Information

    First Posted
    September 24, 2022
    Last Updated
    October 1, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05565664
    Brief Title
    Ketamine Versus Magnesium as Analgesic Adjuvants in Pediatric Adenotonsillectomy
    Official Title
    Ketamine Hydrochloride Versus Magnesium Sulfate as Analgesic Adjuvants in Pediatric Adenotonsillectomy, a Randomized Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    January 2023 (Anticipated)
    Study Completion Date
    March 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Adeno-tonsillectomy is one of the most common surgeries in children. The most common complication associated is postoperative pain. If not well controlled, especially in preschool children, it can lead to a longer recovery period, delayed discharge, and nutritional deficiencies resulting in dehydration. These factors will increase hospitalization period and the need for intravenous fluids. For this purpose, a large number of studies has been designed to evaluate the analgesic effects of various drugs during the perioperative period. Opioids are associated with sedation and respiratory depression, NSAIDs increase the risk of reoperation for bleeding while local anesthetics may cause vasoconstriction of the operation site. For several years, N-methyl-D-aspartate (NMDA) receptors antagonists, such as ketamine and magnesium, have been used successfully to decrease postoperative pain and analgesic requirements in adult patients undergoing a number of different procedures. Ketamine reduces the needed analgesia after tonsillectomy. Most studies have shown that ketamine administration has no side effects such as hemodynamic, respiratory complications and airway problems. Magnesium is a physiological antagonist of the NMDA receptor ion channel that plays a key role in central sensitization. Many studies have investigated the effect of magnesium sulphate on postoperative pain and opioid consumption. However, results of those studies were variable. Whereas most studies describe the reduction of postoperative analgesic requirements after magnesium sulfate, a few studies show insignificant beneficial effects. A previous study evaluated the effect of low dose ketamine (0.15 mg/kg) and magnesium sulfate (30 mg/kg) on post tonsillectomy pain in children, which did not demonstrate a decrease in pain or analgesic consumption in children undergoing tonsillectomy. In this study, the investigators will increase the dose of ketamine to (0.5 mg/kg) and magnesium sulfate to (40 mg/kg) to evaluate their effect on postoperative pain in pediatric patients undergoing adeno-tonsillectomy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Operative Pain, Acute

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    38 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ketamine group
    Arm Type
    Active Comparator
    Arm Description
    After preoperative assessment, participants will receive IM midazolam (0.1 mg/kg) and atropine (0.02 mg/kg) 30 min. before surgery as premedication. Inhalation induction of GA will be done using 8% sevoflurane in 100% oxygen. After insertion of a peripheral IV cannula, IV fentanyl 1 mcg/kg and atracurium 0.5 mg/kg will be given. Direct laryngoscopy will be attempted to insert an age-appropriate cuffed ETT. Patients will be maintained on controlled mechanical ventilation with a mixture of isoflurane in 60% oxygen in air, using a tidal volume of 8cc/kg and a frequency of 16-20 cycle/min. to maintain an ETCO2 35-40 mmHg and to keep an ET isoflurane concentration of 1.5-2%. All patients will receive 10 ml/kg of IV Ringer's solution in the operating room. A single dose of paracetamol 15 mg/kg IV drip will be administered for all patients once they arrive at the PACU. Patients will receive IV ketamine hydrochloride in a dose of 0.5 mg/kg.
    Arm Title
    Magnesium group
    Arm Type
    Active Comparator
    Arm Description
    After preoperative assessment, participants will receive IM midazolam (0.1 mg/kg) and atropine (0.02 mg/kg) 30 min. before surgery as premedication. Inhalation induction of GA will be done using 8% sevoflurane in 100% oxygen. After insertion of a peripheral IV cannula, IV fentanyl 1 mcg/kg and atracurium 0.5 mg/kg will be given. Direct laryngoscopy will be attempted to insert an age-appropriate cuffed ETT. Patients will be maintained on controlled mechanical ventilation with a mixture of isoflurane in 60% oxygen in air, using a tidal volume of 8cc/kg and a frequency of 16-20 cycle/min. to maintain an ETCO2 35-40 mmHg and to keep an ET isoflurane concentration of 1.5-2%. All patients will receive 10 ml/kg of IV Ringer's solution in the operating room. A single dose of paracetamol 15 mg/kg IV drip will be administered for all patients once they arrive at the PACU. Patients will receive IV magnesium sulphate in a dose of 40 mg/kg.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine hydrochloride
    Intervention Description
    Ketamine hydrochloride will be made in a 20 ml syringe in a concentration of 1.25 mg/ml. Patients will receive IV ketamine hydrochloride in a dose of 0.5 mg/kg (equivalent to 0.4 ml/kg) over 10 min. The coordinator of the study will prepare blinded syringes for each group, while the anesthetist who will be in charge of anesthetic management during the operation will be unaware of the study medication.
    Intervention Type
    Drug
    Intervention Name(s)
    Magnesium sulfate
    Intervention Description
    A 20 ml syringe will contain magnesium sulphate in a concentration 100 mg/ml (10%). Patients will receive 40 mg/kg of IV magnesium sulphate (equivalent to 0.4 ml/kg) over 10 min. The coordinator of the study will prepare blinded syringes for each group, while the anesthetist who will be in charge of anesthetic management during the operation will be unaware of the study medication.
    Primary Outcome Measure Information:
    Title
    The postoperative pain score
    Description
    The postoperative pain score after adeno-tonsillectomy using modified Children's Hospital Eastern Ontario Pain Scale (CHEOPS). It is a behavioral scale that includes 6 categories (each has a score from 0 to 2): cry, facial, verbal, torso, legs and touch (with a total score range from 0 to 12). Higher scores mean worse outcome (higher pain intensity).
    Time Frame
    6 hours after surgery
    Secondary Outcome Measure Information:
    Title
    Extubation time
    Description
    The duration between the end of anesthesia and extubation
    Time Frame
    time from discontinuation of volatile anesthetic agent till patient extubation when fully awake, 30 minutes after end of surgery
    Title
    Recovery time
    Description
    the period in minutes from extubation until patient reaches a score of 9 or higher according to modified Aldrete score, when the patients will be ready to transfer to the ward
    Time Frame
    1 hour after end of surgery
    Title
    Heart rate
    Description
    Preoperative, intraoperative and postoperative heart rate (beats per minute)
    Time Frame
    before induction of anesthesia, 1 minute before intubation, 1 minute after intubation, every 10 min intraoperatively, 1 minute before extubation, at admission to post-anesthesia care unit (PACU), 15 and 30 min after PACU admission
    Title
    Mean arterial blood pressure
    Description
    Preoperative, intraoperative and postoperative mean arterial blood pressure (in mmHg)
    Time Frame
    before induction of anesthesia, 1 minute before intubation, 1 minute after intubation, every 10 min intraoperatively, 1 minute before extubation, at admission to post-anesthesia care unit (PACU), 15 and 30 min after PACU admission
    Title
    Postoperative nausea and vomiting in the PACU
    Description
    The incidence of postoperative nausea and vomiting in the PACU (yes or no)
    Time Frame
    1 hour after end of surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Both genders. American society of anesthesiologists (ASA) physical status class I and ll. Patients undergoing adeno-tonsillectomy. Exclusion Criteria: Inability to provide an informed consent. Patients with suspected difficult airway. History of allergy to ketamine or magnesium. Metabolic and endocrine disorders. Growth developmental, and motor-mental retardation.

    12. IPD Sharing Statement

    Learn more about this trial

    Ketamine Versus Magnesium as Analgesic Adjuvants in Pediatric Adenotonsillectomy

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