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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Pediatric ALL; Pediatric Anesthesia

Treatments: Drug: Ketamine; Drug: Saline; Drug: Nalbuphine Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05176119

MS 160/2021

Details and patient eligibility

About

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.

Full 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).

Enrollment: 90 patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

Nalbuphine arm

Active Comparator group

Description:

0.1 mg /kg nalbuphine was given to 30 patients

Treatment:

Drug: Nalbuphine Injection

Ketamine arm

Active Comparator group

Description:

0.25 mg /kg ketamine was given to 30 patients

Treatment:

Drug: Ketamine

Saline arm

Placebo Comparator group

Description:

an equivalent volume of normal saline was given to 30 patients

Treatment:

Drug: Saline