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

Ketamine

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.

Intervention / Treatment

  • Nalbuphine Injection (DRUG)
    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.
  • Ketamine (DRUG)
    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.
  • Saline (DRUG)
    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.

Condition or Disease

  • Pediatric ALL
  • Pediatric Anesthesia

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 4 Years to 10 Years
    Enrollment: 90 (ACTUAL)
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Mar 25, 2021 ACTUAL
    Primary Completion: Jun 25, 2021 ACTUAL
    Completion Date: Jun 25, 2021 ACTUAL
    Study First Posted: Jan 04, 2022 ACTUAL
    Last Updated: Dec 29, 2021

    Sponsors / Collaborators

    Lead Sponsor: Ain Shams University
    Responsible Party: N/A

    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).

    Participant Groups

    • 0.1 mg /kg nalbuphine was given to 30 patients

    • 0.25 mg /kg ketamine was given to 30 patients

    • an equivalent volume of normal saline was given to 30 patients

    Eligibility Criteria

    Sex: All
    Minimum Age: 4
    Maximum Age: 10
    Age Groups: Child
    Healthy Volunteers: Yes

    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

    • 5 step Emergence Agitation scale: describing change in mental status of the children during emergence from general anesthesia. The minimum value is 1 and maximum value is 5, and higher scores mean a better outcome. Score 1 Obtunded with no response to stimulation. Score 2 Asleep but responsive to movement or stimulation Score 3 Awake and responsive Score 4 Crying Score 5 Thrashing behaviour that requires restraint

    Secondary Outcomes

    • 5 step Emergence Agitation scale: describing change in mental status of the children during emergence from general anesthesia. The minimum value is 1 and maximum value is 5, and higher scores mean a better outcome. Score 1 Obtunded with no response to stimulation. Score 2 Asleep but responsive to movement or stimulation Score 3 Awake and responsive Score 4 Crying Score 5 Thrashing behaviour that requires restraint

    • Occurrence of post-operative pain using Modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS). It is a behavioral observational Pain Scale for evaluating postoperative pain in young children. It can be used to monitor the effectiveness of interventions for reducing the pain and discomfort. The minimum value is 0 and maximum value is 10, and higher scores mean a worse condition.

    • It is described as given or not given.

    • duration from receiving the patient in the post anaesthesia care unit till discharge to the ward.it described in the form of minutes.

    • Duration from receiving the patient in the post anesthesia care unit till hospital discharge.it described in the form of hours.

    • described in the from of occurred or not occurred

    • described in the from of occurred or not occurred

    • described in the from of occurred or not occurred

    More Details

    NCT Number: NCT05176119
    Other IDs: MS 160/2021
    Study URL: https://clinicaltrials.gov/study/NCT05176119
    Last updated: Sep 29, 2023