Nalbuphine Versus Ketamine for Prevention of Emergence Agitation After Sevoflurane in Children Undergoing Tonsillectomy
Primary Purpose
Pediatric ALL, Pediatric Anesthesia
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Nalbuphine Injection
Ketamine
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Pediatric ALL focused on measuring Emergence agitation, Ketamine, Nalbuphine, Sevoflurane.
Eligibility Criteria
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 .
Sites / Locations
- Ain Shams university hospitals
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Nalbuphine arm
Ketamine arm
Saline arm
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
Midazolam given for emergence agitation
It is described as given or not given.
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.
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.
Occurrence of postoperative nausea and vomiting
described in the from of occurred or not occurred
Occurrence of laryngeal spasm
described in the from of occurred or not occurred
Post-tonsillectomy bleeding.
described in the from of occurred or not occurred
Full Information
NCT ID
NCT05176119
First Posted
October 19, 2021
Last Updated
December 29, 2021
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT05176119
Brief Title
Nalbuphine Versus Ketamine for Prevention of Emergence Agitation After Sevoflurane in Children Undergoing Tonsillectomy
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
June 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric ALL, Pediatric Anesthesia
Keywords
Emergence agitation, Ketamine, Nalbuphine, Sevoflurane.
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nalbuphine arm
Arm Type
Active Comparator
Arm Description
0.1 mg /kg nalbuphine was given to 30 patients
Arm Title
Ketamine arm
Arm Type
Active Comparator
Arm Description
0.25 mg /kg ketamine was given to 30 patients
Arm Title
Saline arm
Arm Type
Placebo Comparator
Arm Description
an equivalent volume of normal saline was given to 30 patients
Intervention Type
Drug
Intervention Name(s)
Nalbuphine Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
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 Outcome Measure Information:
Title
Emergence Agitation
Description
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
Time Frame
At Time zero (The time of extubation)
Secondary Outcome Measure Information:
Title
Emergence Agitation at post anesthesia care unit(PACU)
Description
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
Time Frame
At time of delivery to PACU
Title
Post-operative pain
Description
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.
Time Frame
30 minutes
Title
Midazolam given for emergence agitation
Description
It is described as given or not given.
Time Frame
30 minutes
Title
Duration in PACU
Description
duration from receiving the patient in the post anaesthesia care unit till discharge to the ward.it described in the form of minutes.
Time Frame
45 minutes
Title
Time to hospital discharge.
Description
Duration from receiving the patient in the post anesthesia care unit till hospital discharge.it described in the form of hours.
Time Frame
6 hours
Title
Occurrence of postoperative nausea and vomiting
Description
described in the from of occurred or not occurred
Time Frame
120 minutes
Title
Occurrence of laryngeal spasm
Description
described in the from of occurred or not occurred
Time Frame
120 minutes
Title
Post-tonsillectomy bleeding.
Description
described in the from of occurred or not occurred
Time Frame
120 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Facility Information:
Facility Name
Ain Shams university hospitals
City
Cairo
State/Province
Al Abbassia
ZIP/Postal Code
11591
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Nalbuphine Versus Ketamine for Prevention of Emergence Agitation After Sevoflurane in Children Undergoing Tonsillectomy
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