NCT05176119

Nalbuphine Versus Ketamine for Prevention of Emergence Agitation After Sevoflurane in Children Undergoing Tonsillectomy

The Effect of Low Dose Nalbuphine or Ketamine in the Prevention of Emergence Agitation After Sevoflurane Anesthesia in Children Undergoing Tonsillectomy With or Without Adenoidectomy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

The effect of low dose nalbuphine or ketamine in the prevention of emergence agitation after sevoflurane anesthesia in children undergoing tonsillectomy with or without adenoidectomy. This randomized double-blind study was carried out at, Ain shams University Hospitals, from March 2021 to June 2021 on 90 patients after approval of the ethical committee.

Detailed description

Emergence agitation (EA) in children is increased after sevoflurane anesthesia. Nalbuphine and midazolam have been used for prophylactic treatment with controversial results. Patients and Methods:Totally, 90 children between 4 and 10 years of age and of American Society of Anesthesiologists I-II undergoing adenotonsillectomy under sevoflurane-based anesthesia were enrolled in the study. Children were randomly allocated to one of the three groups: Group N received nalbuphine 0.1 mg/kg, Group K received ketamine 0.25 mg /kg and Group S received the equivalent volume saline. The study medications was given after discontinuation of sevoflurane by the end of surgery. In the post anesthesia care unit emergence agitation was assessed with emergence agitation scale upon admission (T0), after 5 min (T5), 10 min (T10), 15 min (T15), 20 min (T20), 25 min (T25) and 30 min (T30).

Conditions

• Pediatric ALL
• Pediatric Anesthesia

Interventions

Type	Name	Description
DRUG	Nalbuphine Injection	At the end of the surgery and just before discontinuation of sevoflurane and extubation the study medications will be prepared by the local pharmacy as 10 ml syringes that were handed to the anesthesiologist in charge in OR room who was blinded to the nature of the medications.
DRUG	Ketamine	At the end of the surgery and just before discontinuation of sevoflurane and extubation the study medications will be prepared by the local pharmacy as 10 ml syringes that were handed to the anesthesiologist in charge in OR room who was blinded to the nature of the medications.
DRUG	Saline	At the end of the surgery and just before discontinuation of sevoflurane and extubation the study medications will be prepared by the local pharmacy as 10 ml syringes that were handed to the anesthesiologist in charge in OR room who was blinded to the nature of the medications.

Timeline

• Start date: 2021-03-25
• Primary completion: 2021-06-25
• Completion: 2021-06-25
• First posted: 2022-01-04
• Last updated: 2022-01-04

Locations

1 site across 1 country: Egypt