Ketamine Versus Magnesium as Analgesic Adjuvants in Pediatric Adenotonsillectomy

NCT ID: NCT05565664

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-07-04

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.

Conditions

Post Operative Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Ketamine group

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.

Group Type: ACTIVE_COMPARATOR

Ketamine hydrochloride

Intervention Type: 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 group

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.

Group Type: ACTIVE_COMPARATOR

Magnesium sulfate

Intervention Type: 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.

Interventions

Ketamine hydrochloride

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

Magnesium sulfate

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Kareem Mohammed Assem Nawwar

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jehan Elkholy, M.D.

Role: STUDY_CHAIR

Cairo University

Eman Fouad Ali, M.D.

Role: STUDY_DIRECTOR

Cairo University

Kareem MA Nawwar, M.D.

Role: STUDY_DIRECTOR

Cairo University

Mohamed A Ashour, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of Medicine, Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MD-60-2022

Identifier Type: -

Identifier Source: org_study_id