TonsillectomyPhase 3NCT06122948
Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication on the Occurrence of Postoperative Respiratory Adverse Events
A Phase 3 study testing The midazolam group and The midazolam ketamine group in people with Tonsillectomy and Adenoidectomy, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the effect of addition of intranasal ketamine to midazolam compared to midazolam alone as a premedication on the occurrence of PRAEs Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Tonsillectomy, Adenoidectomy, Drug-Related Side Effects and Adverse Reaction
- What is being tested?
- The midazolam group and The midazolam ketamine group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Nov 2023to 10 Oct 2024
- Phase
- Phase 3
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children both sexes male and female.
- Age from 3 to 12 years old.
- ASA grade I, II.
- undergoing elective AT procedures.
Who cannot join
- Congenital heart diseases (cyanotic and a cyanotic).
- Congenital syndromes affecting airway anatomy such as Pierre-Robin syndrome and Down syndrome.
- Severe lung diseases affecting either lung tissue such as pulmonary cystic fibrosis and idiopathic pulmonary fibrosis or affecting lung circulation such as pulmonary hypertension with marked limitation of Physical activity or inability to carry out any physical activity according to NHYA classification.
- Recent upper respiratory tract infection (less than two weeks).
- Neuromuscular diseases including cerebral palsy and epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication in Children Undergoing Tonsillectomy and Adenoidectomy on the Occurrence of Postoperative Respiratory Adverse Events: a Double-blind, Randomized Controlled Trial
The aim of this study is to investigate the effect of addition of intranasal ketamine to midazolam compared to midazolam alone as a premedication on the occurrence of PRAEs
Read the detailed description
Perioperative respiratory adverse events (PRAEs) are the most common complication during pediatric anesthesia furthermore, most children presenting for AT have sleep-disordered breathing and obstructive sleep apnea syndrome (OSAS) caused by tonsillar hypertrophy which could aggravate the PRAEs specially with the use of the conventional sedatives as a premedication. A recent randomized controlled trial has shown that more than 50% of children premedicated with midazolam had experienced PRAEs . Midazolam and ketamine are commonly used as preoperative sedative drugs for pediatric populations. Ketamine is a safe and widely used sedative and analgesic in the pediatric emergency department (ED) with less profound effects on the upper airway and respiratory muscles. Intranasal ketamine administration is well tolerated and without serious adverse effects. The addition of ketamine to midazolam as a preoperative sedation to reduce the occurrence of PRAEs was not investigated before in children undergoing AT. The authors hypothesize that combination of ketamine to midazolam could offer optimum sedation condition while reducing the occurrence of PRAEs in children undergoing AT.
- Being tested
- The midazolam group, The midazolam ketamine group
- Keywords
- midazolam, ketamine, tonsillectomy, respiratory adverse events
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The midazolam groupDrug
The midazolam group will receive intranasal midazolam (0.1 mg/kg)
The midazolam ketamine groupDrug
the midazolam ketamine group will receive intranasal midazolam (0.1mg/kg) and ketamine (3mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| (Group M) | Active comparator | The midazolam group will receive intranasal midazolam (0.1 mg/kg) Receives: Drug: The midazolam group |
| (Group MK) | Experimental | Midazolam ketamine group will receive intranasal midazolam (0.1mg/kg) and ketamine (3mg/kg) Receives: Drug: The midazolam ketamine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of any perioperative respiratory adverse events (PRAEs)
the incidence of any PRAEs (Perioperative respiratory adverse events (PRAEs) which are manifested as minor (oxygen desaturation (SaO2 less than 95% for 10 seconds) or coughing) and major as (bronchospasm, laryngospasm, airway obstruction, stridor or hypoxia (oxygen desaturation less than 90%)) among midazolam versus midazolam ketamine groups.
Measured: 8 hours
Secondary outcomes (3)
Postoperative pain score
- Postoperative pain score using (Wong-Baker Pain Scale)
Measured: 8 hours
Sedation success rate
- Sedation success rate (score of 3 or 4 is considered successful sedation) using Funk score
Measured: 8 hours
Postoperative emergence delirium
- Postoperative emergence delirium, a total Postoperative emergence delirium PAED score≥ 10 will be considered indicative of the presence of ED using (PAED scale
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start4 Nov 2023
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children will be randomly assigned to 2 groups: the midazolam group will receive intranasal midazolam (0.1 mg/kg), and the midazolam ketamine group will receive intranasal midazolam (0.1mg/kg) and ketamine (3mg/kg) for premedication
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122948
- Sponsor's protocol ID
- MD-227-2023
- Status last verified
- Oct 2024
- First submitted
- 3 Nov 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication in Children Undergoing Tonsillectomy and Adenoidectomy on the Occurrence of Postoperative Respiratory Adverse Events: a Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06122948
- Acronym / sponsor ID
- MD-227-2023
- Keywords
- midazolam, ketamine, tonsillectomy, respiratory adverse events
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 4 Nov 2023 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 8 Nov 2023 (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 aim of this study is to investigate the effect of addition of intranasal ketamine to midazolam compared to midazolam alone as a premedication on the occurrence of PRAEs
Detailed description
Perioperative respiratory adverse events (PRAEs) are the most common complication during pediatric anesthesia furthermore, most children presenting for AT have sleep-disordered breathing and obstructive sleep apnea syndrome (OSAS) caused by tonsillar hypertrophy which could aggravate the PRAEs specially with the use of the conventional sedatives as a premedication. A recent randomized controlled trial has shown that more than 50% of children premedicated with midazolam had experienced PRAEs . Midazolam and ketamine are commonly used as preoperative sedative drugs for pediatric populations. Ketamine is a safe and widely used sedative and analgesic in the pediatric emergency department (ED) with less profound effects on the upper airway and respiratory muscles. Intranasal ketamine administration is well tolerated and without serious adverse effects. The addition of ketamine to midazolam as a preoperative sedation to reduce the occurrence of PRAEs was not investigated before in children undergoing AT. The authors hypothesize that combination of ketamine to midazolam could offer optimum sedation condition while reducing the occurrence of PRAEs in children undergoing AT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Children will be randomly assigned to 2 groups: the midazolam group will receive intranasal midazolam (0.1 mg/kg), and the midazolam ketamine group will receive intranasal midazolam (0.1mg/kg) and ketamine (3mg/kg) for premedication
| Arm | Type | Receives |
|---|---|---|
| (Group M) | Active comparator | Drug: The midazolam groupThe midazolam group will receive intranasal midazolam (0.1 mg/kg) |
| (Group MK) | Experimental | Drug: The midazolam ketamine groupMidazolam ketamine group will receive intranasal midazolam (0.1mg/kg) and ketamine (3mg/kg) |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children both sexes male and female.
- Age from 3 to 12 years old.
- ASA grade I, II.
- undergoing elective AT procedures.
Key exclusion criteria (5 listed)
- Congenital heart diseases (cyanotic and a cyanotic).
- Congenital syndromes affecting airway anatomy such as Pierre-Robin syndrome and Down syndrome.
- Severe lung diseases affecting either lung tissue such as pulmonary cystic fibrosis and idiopathic pulmonary fibrosis or affecting lung circulation such as pulmonary hypertension with marked limitation of Physical activity or inability to carry out any physical activity according to NHYA classification.
- Recent upper respiratory tract infection (less than two weeks).
- Neuromuscular diseases including cerebral palsy and epilepsy.
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 |
|---|---|---|
| The midazolam groupThe midazolam group will receive intranasal midazolam (0.1 mg/kg) | Drug | (Group M) |
| The midazolam ketamine groupthe midazolam ketamine group will receive intranasal midazolam (0.1mg/kg) and ketamine (3mg/kg) | Drug | (Group MK) |
Primary outcome
The incidence of any perioperative respiratory adverse events (PRAEs)
Time frame: 8 hours
the incidence of any PRAEs (Perioperative respiratory adverse events (PRAEs) which are manifested as minor (oxygen desaturation (SaO2 less than 95% for 10 seconds) or coughing) and major as (bronchospasm, laryngospasm, airway obstruction, stridor or hypoxia (oxygen desaturation less than 90%)) among midazolam versus midazolam ketamine groups.
3 secondary outcomes
Postoperative pain score
Time frame: 8 hours
Sedation success rate
Time frame: 8 hours
Postoperative emergence delirium
Time frame: 8 hours
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 15 Oct 2024.
- 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 3 study testing The midazolam group and The midazolam ketamine group in people with Tonsillectomy and Adenoidectomy, run by Kasr El Aini Hospital 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 5 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 15 Oct 2024. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The incidence of any perioperative respiratory adverse events (PRAEs) (time frame: 8 hours). 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 15 Oct 2024.