Pediatric ALL, Pediatric Anesthesia
Conditions
Keywords
Emergence agitation, Ketamine, Nalbuphine, Sevoflurane.
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).
Interventions
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.
DRUGKetamine
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.
DRUGSaline
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergence Agitation | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to hospital discharge. | 6 hours | Duration from receiving the patient in the post anesthesia care unit till hospital discharge.it described in the form of hours. |
| Occurrence of postoperative nausea and vomiting | 120 minutes | described in the from of occurred or not occurred |
| Occurrence of laryngeal spasm | 120 minutes | described in the from of occurred or not occurred |
| Duration in PACU | 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. |
| Post-operative pain | 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. |
| Midazolam given for emergence agitation | 30 minutes | It is described as given or not given. |
| Post-tonsillectomy bleeding. | 120 minutes | described in the from of occurred or not occurred |
| Emergence Agitation at post anesthesia care unit(PACU) | 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 |
Countries
Egypt
Outcome results
None listed