Clinical trial NCT05565664: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Pain, Acute
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 38
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The postoperative pain score
timeFrame: 6 hours after surgery
Secondary outcomes:
measure: Extubation time
timeFrame: time from discontinuation of volatile anesthetic agent till patient extubation when fully awake, 30 minutes after end of surgery
measure: Recovery time
timeFrame: 1 hour after end of surgery
measure: Heart rate
timeFrame: 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
measure: Mean arterial blood pressure
timeFrame: 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
measure: Postoperative nausea and vomiting in the PACU
timeFrame: 1 hour after end of surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University
Study officials:
affiliation: Cairo University
name: Jehan Elkholy, M.D.
role: STUDY_CHAIR
affiliation: Cairo University
name: Eman Fouad Ali, M.D.
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Kareem MA Nawwar, M.D.
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Mohamed A Ashour, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: