Pediatric ALLPhase 4NCT05176119
Nalbuphine Versus Ketamine for Prevention of Emergence Agitation After Sevoflurane in Children Undergoing Tonsillectomy
A Phase 4 study testing Nalbuphine Injection, Ketamine and Saline in people with Pediatric ALL and Pediatric Anesthesia, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Pediatric ALL, Pediatric Anesthesia
- What is being tested?
- Nalbuphine Injection, Ketamine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2021to 25 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients undergoing tonsillectomy with or without adenoidectomy
- Age 4 - 10 years.
- Sex: Both sexes
- Patients with ASA classificaion I and II.
Who cannot join
- 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 .
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- Hearing defect .
- Neurological disorder.
- Family history of malignant hyperthermia .
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Pediatric ALL, Pediatric Anesthesia
- Being tested
- Nalbuphine Injection, Ketamine, Saline
- Keywords
- Emergence agitation, Ketamine, Nalbuphine, Sevoflurane.
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalbuphine InjectionDrug
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.
KetamineDrug
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.
SalineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Nalbuphine arm | Active comparator | 0.1 mg /kg nalbuphine was given to 30 patients Receives: Drug: Nalbuphine Injection |
| Ketamine arm | Active comparator | 0.25 mg /kg ketamine was given to 30 patients Receives: Drug: Ketamine |
| Saline arm | Placebo comparator | an equivalent volume of normal saline was given to 30 patients Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At Time zero (The time of extubation)
Secondary outcomes (8)
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
Measured: 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.
Measured: 30 minutes
Midazolam given for emergence agitation
It is described as given or not given.
Measured: 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.
Measured: 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.
Measured: 6 hours
Occurrence of postoperative nausea and vomiting
described in the from of occurred or not occurred
Measured: 120 minutes
Occurrence of laryngeal spasm
described in the from of occurred or not occurred
Measured: 120 minutes
Post-tonsillectomy bleeding.
described in the from of occurred or not occurred
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start25 Mar 2021
- Primary completion25 Jun 2021
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diaaeldein Mahmoud Haiba, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176119
- Sponsor's protocol ID
- MS 160/2021
- Status last verified
- Dec 2021
- First submitted
- 19 Oct 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05176119
- Acronym / sponsor ID
- MS 160/2021
- Conditions
- Pediatric ALL, Pediatric Anesthesia
- Keywords
- Emergence agitation, Ketamine, Nalbuphine, Sevoflurane.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nalbuphine arm | Active comparator | Drug: Nalbuphine Injection0.1 mg /kg nalbuphine was given to 30 patients |
| Ketamine arm | Active comparator | Drug: Ketamine0.25 mg /kg ketamine was given to 30 patients |
| Saline arm | Placebo comparator | Drug: Salinean equivalent volume of normal saline was given to 30 patients |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients undergoing tonsillectomy with or without adenoidectomy
- Age 4 - 10 years.
- Sex: Both sexes
- Patients with ASA classificaion I and II.
Key exclusion criteria (9 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nalbuphine InjectionAt 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. | Drug | Nalbuphine arm |
| KetamineAt 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. | Drug | Ketamine arm |
| SalineAt 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. | Drug | Saline arm |
Primary outcome
Emergence Agitation
Time frame: 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
8 secondary outcomes
Emergence Agitation at post anesthesia care unit(PACU)
Time frame: At time of delivery to PACU
Post-operative pain
Time frame: 30 minutes
Midazolam given for emergence agitation
Time frame: 30 minutes
Duration in PACU
Time frame: 45 minutes
Time to hospital discharge.
Time frame: 6 hours
Occurrence of postoperative nausea and vomiting
Time frame: 120 minutes
Occurrence of laryngeal spasm
Time frame: 120 minutes
Post-tonsillectomy bleeding.
Time frame: 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nalbuphine Injection, Ketamine and Saline in people with Pediatric ALL and Pediatric Anesthesia, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence Agitation (time frame: At Time zero (The time of extubation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.