Nalbuphine Versus Ketamine for Prevention of Emergence Agitation After Sevoflurane in Children Undergoing Tonsillectomy
- Conditions
- Pediatric ALLPediatric Anesthesia
- Interventions
- Registration Number
- NCT05176119
- Lead Sponsor
- Ain Shams University
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Pediatric patients undergoing tonsillectomy with or without adenoidectomy
- Age 4 - 10 years.
- Sex: Both sexes
- Patients with ASA classificaion I and II.
- 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 .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nalbuphine arm Nalbuphine Injection 0.1 mg /kg nalbuphine was given to 30 patients Saline arm Saline an equivalent volume of normal saline was given to 30 patients Ketamine arm Ketamine 0.25 mg /kg ketamine was given to 30 patients
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Midazolam given for emergence agitation 30 minutes It is described as given or not given.
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.
Occurrence of laryngeal spasm 120 minutes described in the from of occurred or not occurred
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
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
Trial Locations
- Locations (1)
Ain Shams university hospitals
🇪🇬Cairo, Al Abbassia, Egypt
Ain Shams university hospitals🇪🇬Cairo, Al Abbassia, Egypt