Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Children are prone to anxiety and even fear before surgery, and such adverse emotions may not only lead to poor induction of anesthesia, but also increase the incidence of postoperative agitation and even lead to postoperative behavioral changes in children. There are many ways to relieve pediatric anxiety, including preoperative medication, games, and cartoons. Preoperative medication is the most commonly used method to relieve pediatric anxiety.The most commonly used pediatric preoperative sedation drugs are midazolam and esketamine.However, oral midazolam may not produce a sedative effect in 20-40% of patients. A good preoperative anxiety-reducing effect was seen in only 60-80% of cases.Therefore, this trial investigates whether the intranasal combination of esketamine with oral midazolam can produce better results than each of the two drugs alone. This will provide a reference for the selection of safe, reliable and appropriate preoperative sedation methods for pediatric patients and provide evidence-based support for comfort care.
A trained member of the research team obtained a baseline The Modified Yale Preoperative Anxiety Scale(mYPAS) after obtaining consent. And corresponding study medication is administered about 30-40 minutes before the anesthesia induction.Vital signs were measured every 5 min after study medication administration.The sedation scores of the children were recorded with University of Michigan Sedation Scale (UMSS) every 10 minutes.The onset time of satisfactory sedation and parental separation anxiety scale was noted.Then recorded the degree of cooperation during inhalation anesthesia induction and recovery times.Moreover, recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| midazolam | Placebo Comparator | Patients were assigned to receive oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table. |
|
| esketamine | Experimental | Patients were assigned to receive intranasal esketamine 1mg/kg approximately 30-40 minutes before surgery using a computer-generated random number table. |
|
| midazolam and esketamine | Experimental | Patients were assigned to receive intranasal esketamine 0.6mg/kg and oral midazolam 0.3mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The degree of cooperation during inhalation anesthesia induction | Induction Compliance Checklist range from 0 through 10,and lower scores indicate the higher degree of cooperation during inhalation anesthesia induction | During inhalation anesthesia induction |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety before induction of anesthesia | The Modified Yale Preoperative Anxiety Scale: The 22-item measure has five behavioural categories: activity, emotional expressivity, alertness and arousal, vocalizations, and interaction with parents. Total scores range from 23.33 through 100 with higher scores indicating greater anxiety. | Each 10 minutes during the forty minutes of preoperative period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huacheng Liu | Contact | 18957755138 | huachengliu@163.com | |
| Xulin Zhang | Contact | 18583748800 | 867237394@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Huacheng Liu | Second Affiliated Hospital of Wenzhou Medical University | Principal Investigator |
| Xulin Zhang | Second Affiliated Hospital of Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D008874 | Midazolam |
| C000629870 | Esketamine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Esketamine | Drug | intranasal esketamine 1mg/kg approximately 30-40 mins before surgery using a computer-generated random number table. |
|
|
| midazolam and esketamine | Drug | oral midazolam 0.3mg/kg and intranasal esketamine 0.6mg/kg approximately 30-40 mins before surgery using a computer-generated random number table. |
|
|
| The level of sedation | University of Michigan Sedation Scale: 0 -Awake/Alert 1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds. 2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation. 3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation. 4 - Unarousable. higher scores mean a higher levels of sedation. | Each 10 minutes during the forty minutes of preoperative period |
| Parental separation anxiety scale | A four-point parental separation anxiety scale as follows:
The scores of 1 and 2 signified acceptable separation whereas scores of 3 and 4 were classified as difficult separation. | During the preoperative period |
| Recovery times | The time from discontinuation of sevoflurane to the first open eye of the children and to achieve aldrete≥9 | Within up to 30 minutes after child's first eye opening in the postoperative period |
| Pediatric anesthesia emergence delirium | The pediatric anesthesia emergence delirium scale consists of four items. Each item is scored 0-4 yielding a total between 0 and 20. The degree of emergence delirium increased directly with the total score.pediatric anesthesia emergence delirium scale ≥12 at any time indicates presence of emergence delirium. | Within up to 15-30 minutes after child's first eye opening in the postoperative period |
| Number of children with adverse effects | Number of children with adverse effects
| Up to 24 hours including preoperative, intraoperative, and postoperative periods |
| D006571 | Heterocyclic Compounds |