Intranasal Dexmedetomidine Premedication in Children
キーワード
概要
説明
After Institutional Review Board (IRB) approval and written informed consent from patients' parents or legally authorized representative, 80 children older than 5yrs and weighing more than 20kg, ASA physical status 1 or 2, scheduled for elective dental rehabilitation with general anesthesia will be enrolled in this prospective randomized double blinded study.
Exclusion criteria include known allergy or hypersensitivity to midazolam or dexmedetomidine, uncorrected congenital heart disease or history of cardiac arrhythmia, children at risk for airway obstruction (OSA or cranio facial syndrome) and pregnant minors Patients will be randomly assigned to one of two groups M (midazolam) or D (dexmedetomidine) using computer-generated numbers in sealed envelopes.
All the patients will be brought to their pre-op room and premedicated at least 30 min before induction of anesthesia.
In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup.
In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R). The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM). Atomized nasal medications offer rapid absorption across mucosal membranes to the blood stream avoiding first-pass metabolism.
Parents will be present in the room during premedication. The Anesthesia personnel involved in the care of the patient (MD or CRNA) will prepare and administer all study drugs. All patients will be continuously monitored in the holding area with pulse oximetry and blood pressure monitor. HR, SPO2 and BP will be recorded every 15min after administration of premedication until transfer to the OR. Emergency medications including atropine and epinephrine will be immediately available in the pre-op holding area. Oral midazolam has been used with very little effect on hemodynamic parameters. Although intranasal dexmedetomidine can decrease HR and BP, it has been used at the dose of 2mcg/kg without any adverse hemodynamic effect . Any intervention needed to treat drop in HR (<50) and BP (sys BP <60) after the drug administration will be recorded.
Behavior of the children at the time of premedication will be documented ( easy or difficult). Any unwanted effects during administration such as spitting or vomiting of oral drug and pain or irritation from nasal administration will be documented.
The dental resident blinded to study drug administration will do the pre-operative sedation status and acceptance of mask induction.
Sedation status will be assessed using University of Michigan sedation scale (UMSS)on separation from parents and at induction after moving to the OR table. Acceptance of mask induction will be documented on a 4-point scale.
Standard ASA monitors will be applied before induction of anesthesia. All patients will undergo mask induction with O2/N2O/Sevo. An intravenous line will be inserted and secured. Both nostrils will be prepped nasal drops and tips of tracheal tubes covered with red rubber to minimize bleeding. Nasal intubation will be performed with direct laryngoscopy and McGill's forceps. Appropriate size cuffed tracheal tubes will be inserted and secured after additional IV medications with propofol 2-3mg/kg and fentanyl 1-2mcg/kg. Anesthesia will be maintained with O2/Sevo, IV morphine 0.05 to 0.1mg/kg and IV toradol 0.5mg/kg (if there is no allergy or contraindication to morphine or toradol) After the completion of procedure, patients will be extubated in the operating room and brought to recovery room and allowed to wake up slowly in the recovery position.
PACU nurses will evaluate Behavior at awakening using four-point wake up score (9,20). Patients will also be asked if they remember mask induction (yes or no) when they are ready for discharge. Incidence of nausea, vomiting, shivering will be documented in PACU. Time spent in phase 1 recovery room will also be recorded .
日付
最終確認済み: | 05/31/2017 |
最初に提出された: | 09/04/2014 |
提出された推定登録数: | 09/24/2014 |
最初の投稿: | 09/25/2014 |
最終更新が送信されました: | 06/28/2017 |
最終更新日: | 07/06/2017 |
最初に提出された結果の日付: | 01/08/2017 |
最初に提出されたQC結果の日付: | 06/28/2017 |
最初に投稿された結果の日付: | 07/06/2017 |
実際の研究開始日: | 08/31/2014 |
一次完了予定日: | 08/31/2016 |
研究完了予定日: | 08/31/2016 |
状態または病気
介入/治療
Drug: Midazolam
Drug: Dexmedetomidine
段階
アームグループ
腕 | 介入/治療 |
---|---|
Active Comparator: Midazolam In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication | Drug: Midazolam oral midazolam 0.5mg/kg upto maximum dose of 15mg |
Experimental: Dexmedetomidine In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM). | Drug: Dexmedetomidine intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg |
適格基準
研究の対象となる年齢 | 5 Years に 5 Years |
研究に適格な性別 | All |
健康なボランティアを受け入れる | はい |
基準 | Inclusion Criteria: - Children older than 5yrs and weighing more than 20kg , who are scheduled for ambulatory dental rehabilitation at Batson operating rooms. - ASA classification 1 or 2 Exclusion Criteria - Known allergy to midazolam, dexmedetomidine,morphine, fentanyl, sevoflurane and propofol. - uncorrected congenital heart disease or history of cardiac arrhythmia, - children at risk for airway obstruction (OSA or cranio facial syndrome), - pregnant minors |
結果
主な結果の測定
1. University of Michigan Sedation Scale [Day 0:Just before the patient will be brought to the operating room]
二次的な結果の測定
1. Acceptance of Mask Induction [Day 0: At the time when anesthesia is induced]
2. Wake up Behavior [Day 0: At the end of surgery when the patient recovers from anesthesia]
3. Presence of Amnesia to Mask Induction [Day 0: at the time of discharge of the patient from the recovery room]