Clinical trial NCT05176119: Nalbuphine Versus Ketamine for Prevention of Emergence Agitation After Sevoflurane in Children Undergoing Tonsillectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pediatric ALL
Pediatric Anesthesia
Keywords: Emergence agitation
Ketamine
Nalbuphine
Sevoflurane.
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Eligibility criteria: Inclusion Criteria:

Pediatric patients undergoing tonsillectomy with or without adenoidectomy

1. Age 4 - 10 years.
2. Sex: Both sexes
3. Patients with ASA classificaion I and II.

Exclusion Criteria:

1. Declining to give written informed consent.
2. History of allergy to the medications used in the study.
3. psychiatric disorder.
4. ASA classification III-V.
5. Fever ,cough , asthma or upper respiratory tract infection .
6. Anticipated difficult airway .
7. Hearing defect .
8. Neurological disorder.
9. Family history of malignant hyperthermia .

Primary outcomes:
measure: Emergence Agitation
timeFrame: At Time zero (The time of extubation)
Secondary outcomes:
measure: Emergence Agitation at post anesthesia care unit(PACU)
timeFrame: At time of delivery to PACU
measure: Post-operative pain
timeFrame: 30 minutes
measure: Midazolam given for emergence agitation
timeFrame: 30 minutes
measure: Duration in PACU
timeFrame: 45 minutes
measure: Time to hospital discharge.
timeFrame: 6 hours
measure: Occurrence of postoperative nausea and vomiting
timeFrame: 120 minutes
measure: Occurrence of laryngeal spasm
timeFrame: 120 minutes
measure: Post-tonsillectomy bleeding.
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university hospitals
state: Al Abbassia
Study officials:
References: