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NCT Number: 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.

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.

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Key information

Conditions

Pediatric ALL Confusion Delirium Emergence Delirium Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Mental Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Anesthesia Postoperative Complications Precursor Cell Lymphoblastic Leukemia-Lymphoma Signs and Symptoms

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams university hospitals

Cairo, Al Abbassia, 11591, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pediatric patients undergoing tonsillectomy with or without adenoidectomy

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Emergence Agitation

    Time frame: At Time zero (The time of extubation)

    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

  1. Emergence Agitation at post anesthesia care unit(PACU)

    Time frame: At time of delivery to PACU

    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

  2. Post-operative pain

    Time frame: 30 minutes

    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.

  3. Midazolam given for emergence agitation

    Time frame: 30 minutes

    It is described as given or not given.

  4. Duration in PACU

    Time frame: 45 minutes

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

  5. Time to hospital discharge.

    Time frame: 6 hours

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

  6. Occurrence of postoperative nausea and vomiting

    Time frame: 120 minutes

    described in the from of occurred or not occurred

  7. Occurrence of laryngeal spasm

    Time frame: 120 minutes

    described in the from of occurred or not occurred

  8. Post-tonsillectomy bleeding.

    Time frame: 120 minutes

    described in the from of occurred or not occurred

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 4, 2022
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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