scale measuring level of sedation from 1-6 points. 1 is referring to no sedation and 6 is the maximum sedation. reaching score of 4 is the sedation level needed to insert the cannula.
Comparison Between Dexmeditomidine, Midazolam and Ketamine as a Sedative to Help Cannula Insertion in Pediatric Patient
Brief Summary
Background and Objectives: Surgery and hospitalization present a very stressful period for children and their parents. The induction of anesthesia and cannula insertion may be the only bad experience a child can remember during his procedure. Pediatric intravenous cannulation is technically difficult and moreover may cause psychological problems. Sedative Premedication has a great role in pediatric anesthesia to overcome fear and anxiety and to facilitate easy separation from their parents. Intranasal approach is safe and painless and well tolerated by children in addition to a comparable onset of action with the intravenous approach. Midazolam, dexmedetomidine and ketamine have proved their effectiveness as a sedative premedication. The objective of the current study was to compare the effectiveness of administration of intranasal midazolam, dexmedetomidine and ketamine as sedatives to facilitate and decrease the discomfort of intravenous cannulation before surgery in children undergoing various surgical procedures. Methods: the patients agreed to participate in the research were classified into 3 groups. Dexmedetomidine, Midazolam and Ketamine group; each group received the intranasal drug 30 min before the procedure. Pulse, MAP, oxygen saturation and sedation score (MOAA/S) baseline and every 10 min. Easiness of venipuncture, parental separation and any complication encountered were recorded.
Intervention / Treatment
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Ketamine (DRUG)ketamine intranasal injection,2 mg/kg, once, 30 min preoperative
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Midazolam (DRUG)midazolam intranasal injection,0.2mg/kg, once, 30 min preoperative
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Dexmedetomidine (DRUG)dexmedetomidine intranasal injection,1 μg/kg, once, 30 min preoperative
Condition or Disease
- Cannula Site Pain
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 2 Years to 9 Years |
| Enrollment: | 150 (ACTUAL) |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
MaskingQUADRUPLE:
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Clinical Trial Dates
| Start date: | Jan 01, 2021 | ACTUAL |
|---|---|---|
| Primary Completion: | Feb 15, 2021 | ACTUAL |
| Completion Date: | Feb 15, 2021 | ACTUAL |
| Study First Posted: | Jan 11, 2021 | ACTUAL |
| Last Updated: | May 26, 2021 |
Sponsors / Collaborators
Lead Sponsor:
Ain Shams University
Responsible Party:
N/A
Background and Objectives: Surgery and hospitalization present a very stressful period for children and their parents. The induction of anesthesia and cannula insertion may be the only bad experience a child can remember during his procedure. Pediatric intravenous cannulation is technically difficult and moreover may cause psychological problems. Sedative Premedication has a great role in pediatric anesthesia to overcome fear and anxiety and to facilitate easy separation from their parents. Intranasal approach is safe and painless and well tolerated by children in addition to a comparable onset of action with the intravenous approach. Midazolam, dexmedetomidine and ketamine have proved their effectiveness as a sedative premedication. We assumed that intranasal midazolam, dexmedetomidine and ketamine would help anesthetics to carry out venous cannulation easily; in addition to their sedative premedication effect.
The objective of the current study was to compare the effectiveness of administration of intranasal midazolam, dexmedetomidine and ketamine as sedatives to facilitate and decrease the discomfort of intravenous cannulation before surgery in children undergoing various surgical procedures.
Study design: 150 patients agreed to participate in the research after written informed consent. patients were classified into 3 groups. Dexmedetomidine, Midazolam and Ketamine group; each group received the intranasal drug 30 min before the procedure. Pulse, MAP, oxygen saturation and sedation score (MOAA/S) baseline and every 10 min. Easiness of venipuncture, parental separation and any complication encountered were recorded. Group assignment, preparation and administration of drugs will be performed by a junior anesthetist who is neither involved nor interested by any means in the study.
The objective of the current study was to compare the effectiveness of administration of intranasal midazolam, dexmedetomidine and ketamine as sedatives to facilitate and decrease the discomfort of intravenous cannulation before surgery in children undergoing various surgical procedures.
Study design: 150 patients agreed to participate in the research after written informed consent. patients were classified into 3 groups. Dexmedetomidine, Midazolam and Ketamine group; each group received the intranasal drug 30 min before the procedure. Pulse, MAP, oxygen saturation and sedation score (MOAA/S) baseline and every 10 min. Easiness of venipuncture, parental separation and any complication encountered were recorded. Group assignment, preparation and administration of drugs will be performed by a junior anesthetist who is neither involved nor interested by any means in the study.
Participant Groups
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dexmedetomidine intranasal injection,1 μg/kg, once, 30 min preoperative
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ketamine intranasal injection,2 mg/kg, once, 30 min preoperative
-
midazolam intranasal injection,0.2 mg/kg, once, 30 min preoperative
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 2 |
| Maximum Age: | 9 |
| Age Groups: | Child |
| Healthy Volunteers: | Yes |
Inclusion Criteria: all the following must be included
* child aged between 2-9 years scheduled for minor elective surgical procedures (last 1-2 hours) at pediatric surgery department.
* Patients were ASA I or II.
* within normal range of weight.
* refusing venous cannulation
Exclusion Criteria: any of the following
* parents' refusal
* with nasal deformity or pathology
* any known case of allergy to the study drugs
* obese patients
* suspected difficult airway or venous cannulation.
* maxillofacial malformations
* gastroesophageal reflux
* patients with renal, liver, endocrine or cardiac pathology
* patients with increased intracranial or intraocular pressure
* patients with sleep apnea
* any patient with a preexisting cannula or accepting cannula insertion
* child aged between 2-9 years scheduled for minor elective surgical procedures (last 1-2 hours) at pediatric surgery department.
* Patients were ASA I or II.
* within normal range of weight.
* refusing venous cannulation
Exclusion Criteria: any of the following
* parents' refusal
* with nasal deformity or pathology
* any known case of allergy to the study drugs
* obese patients
* suspected difficult airway or venous cannulation.
* maxillofacial malformations
* gastroesophageal reflux
* patients with renal, liver, endocrine or cardiac pathology
* patients with increased intracranial or intraocular pressure
* patients with sleep apnea
* any patient with a preexisting cannula or accepting cannula insertion
Primary Outcomes
Secondary Outcomes
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measuring pulse rate/ minutes every 10 minutes at baseline till the end of surgery
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measuring Mean Arterial Pressure every 10 minutes at baseline till the end of surgery
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measuring oxygen saturation every 10 minutes at baseline till the end of surgery
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poor, fair, good, excellent
More Details
| NCT Number: | NCT04704622 |
|---|---|
| Other IDs: | Rasha Abusinna |
| Study URL: | https://clinicaltrials.gov/study/NCT04704622 |
Last updated: Sep 29, 2023