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

Pediatric ALL Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05176119
• Other study ID #: MS 160/2021
• Status: Completed
• Phase: Phase 4
• Start date: March 25, 2021
• Est. completion date: June 25, 2021

Study information

• Verified date: December 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 25, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Emergence Delirium
• Pediatric ALL
• Pediatric Anesthesia
• Psychomotor Agitation

Intervention

Drug:
• Nalbuphine Injection
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
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
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.

Locations

Country	Name	City	State
Egypt	Ain Shams university hospitals	Cairo	Al Abbassia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Midazolam given for emergence agitation	It is described as given or not given.	30 minutes
Secondary	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
Secondary	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
Secondary	Occurrence of postoperative nausea and vomiting	described in the from of occurred or not occurred	120 minutes
Secondary	Occurrence of laryngeal spasm	described in the from of occurred or not occurred	120 minutes
Secondary	Post-tonsillectomy bleeding.	described in the from of occurred or not occurred	120 minutes