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NCT Number: NCT05565664

Ketamine Versus Magnesium as Analgesic Adjuvants in Pediatric Adenotonsillectomy

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.

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Key information

Conditions

Post Operative Pain, Acute Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketamine Hydrochloride

Drug

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.

Magnesium sulfate

Drug

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 outcomes

  1. The postoperative pain score

    Time frame: 6 hours after surgery

    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 outcomes

  1. Extubation time

    Time frame: time from discontinuation of volatile anesthetic agent till patient extubation when fully awake, 30 minutes after end of surgery

    The duration between the end of anesthesia and extubation

  2. Recovery time

    Time frame: 1 hour after end of surgery

    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

  3. Heart rate

    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

    Preoperative, intraoperative and postoperative heart rate (beats per minute)

  4. Mean arterial blood pressure

    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

    Preoperative, intraoperative and postoperative mean arterial blood pressure (in mmHg)

  5. Postoperative nausea and vomiting in the PACU

    Time frame: 1 hour after end of surgery

    The incidence of postoperative nausea and vomiting in the PACU (yes or no)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Ketamine Hydrochloride Versus Magnesium Sulfate as Analgesic Adjuvants in Pediatric Adenotonsillectomy, a Randomized Comparative Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 4, 2022
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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