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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Pediatric ALL, Pediatric Anesthesia

Intervention / Treatment
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* Drug: Nalbuphine Injection
* Drug: Ketamine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nalbuphine arm<br>0.1 mg /kg nalbuphine was given to 30 patients | Drug: Nalbuphine Injection<br>* 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.<br>|
| Active Comparator: Ketamine arm<br>0.25 mg /kg ketamine was given to 30 patients | Drug: Ketamine<br>* 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.<br>|
| Placebo Comparator: Saline arm<br>an equivalent volume of normal saline was given to 30 patients | Drug: Saline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence Agitation | 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 | At Time zero (The time of extubation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence Agitation at post anesthesia care unit(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 | At time of delivery to PACU | 
| Post-operative pain | 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. | 30 minutes | 
| Midazolam given for emergence agitation | It is described as given or not given. | 30 minutes | 
| Duration in PACU | duration from receiving the patient in the post anaesthesia care unit till discharge to the ward.it described in the form of minutes. | 45 minutes | 
| Time to hospital discharge. | Duration from receiving the patient in the post anesthesia care unit till hospital discharge.it described in the form of hours. | 6 hours | 
| Occurrence of postoperative nausea and vomiting | described in the from of occurred or not occurred | 120 minutes | 
| Occurrence of laryngeal spasm | described in the from of occurred or not occurred | 120 minutes | 
| Post-tonsillectomy bleeding. | described in the from of occurred or not occurred | 120 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergence agitation, Ketamine, Nalbuphine, Sevoflurane.