The Effectiveness of Intra-osseous Anaesthesia in Reducing Immediate and Delayed Post-operative Complications Associated With the Extraction of First Permanent Molars Under General Anaesthesia: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- postoperative delirium in the child (flowchart)
研究概览
简要总结
The investigators are doing a study to see if a new way of giving local anesthesia during dental surgery can help children feel better after having a tooth removed under general anesthesia (when they are fully asleep). Normally, dentists give numbing medicine that can leave the lips or cheeks numb. This sometimes causes children to bite themselves without realizing it, which can make them upset when they wake up. In this study, the investigators are testing a special technique called intra-osseous anesthesia, which numbs only the tooth and not the surrounding soft tissues. The investigators hope this will reduce pain after surgery without causing numbness or accidental biting. Children in the study will be randomly placed into one of two groups: one group will receive this special anesthesia before the tooth is removed, and the other group will not. Before and after the procedure, the investigators will ask some short questions and observe the participants to check for pain, anxiety, or confusion. The parents of the participants will also receive a short online questionnaire to fill out the day after the procedure. The goal is to find out if this method helps children wake up more comfortably, feel less pain, and avoid side effects. This could improve how dentists care for children during dental treatments in the future.
详细描述
To investigate whether the administration of intra-osseous local anesthesia (Quicksleeper 5) to children during general anesthesia prior to the extraction of a first permanent molar has an effect on the immediate and delayed postoperative delirium, anxiety and pain in the child.
Intra-osseous anesthesia consists of 3 major steps:
- Limited superficial anesthesia of the mucosa at the level of the tooth to be treated/extracted
- Perforation of the bone by means of a rotating needle movement
- Injection of the local anesthetic directly into the bone The operator (AG) will administer the intra-osseous anesthesia just before the tooth(s) are extracted. The extractions will always be performed at the end of the dental treatment.
A permanent molar must be removed from the child and this will be done under general anesthesia. Previous scientific studies have shown that when the dentist also administers local anesthesia during general anesthesia for tooth removal, children suffer from side effects of the local anesthesia. These side effects include numbness and lip or cheek biting. This can make them extra agitated when waking up from general anesthesia.
This intra-osseous anesthesia technique only anesthetizes the tooth. As a result, the child should not experience the above-mentioned side effects or to a lesser extent. In this study,The investigators want to investigate this effect. The advantage of this technique is that the child is expected to need little or no painkillers after the operation compared to the current procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Blinding is performed using a 6 digit code generated randomly using www.random.org. This code shall be used in all the patients files and shall only be known to the trial administrator.
It is a double blind study in which the operator knows whether she is giving intra-osseus anesthesia (articaine) or not, but the patient and the evaluator of the pre- and post- operative scales will not know if the patient got local anaesthesia or not.
SR has the excel file with the results of the block randomisation and key for blinding (pseudonymization).
Allocation concealment will be performed by with the sealed envelope technique.SR is independent of the study results. He has no access to the results of the patients.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Children between 6 and 12 years old, belonging to the category of ASA I or II according to the 'American Society of Anaesthesiologists'
- •Children who are cooperative enough for pre- and post-operative measurements
- •Children who are not allergic to components of local anaesthesia
- •Children who need at least one extraction of a FPM
- •Children without a hematological condition
- •Children who haven't taken painkillers 48 hours before the procedure
- •Patients who need a treatment under general anaesthesia (nasal intubation) due to polycaries/fear/anxiety.
- •Able to obtain a written consent from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes
排除标准
- •- Treatment with a laryngeal mask
- •If a traumatic extraction is needed, this patient is excluded from the study
- •Children who do not meet the inclusion criteria
- •Deviation in the pain relief protocol
- •Parents/child don't speak Dutch
- •Patients with missing data during the procedure/follow-up
研究组 & 干预措施
intra osseous administration of local anesthesia during general anesthesia
Intra osseous administration of articain 4% 1/100 000 during general anesthesia for the extraction of a first permanent molar. The administration will be done with Quicksleeper 5.
干预措施: Administration of intra-osseous local anesthesia before the extraction of a first permanent molar under general anesthesia (Other)
Control group
Normal procedure: no local anesthesia for the extraction of a first permanent molar during general anesthesia
结局指标
主要结局
postoperative delirium in the child (flowchart)
时间窗: 5 minutes after spontaneous eye opening
to investigate whether the administration of intra-osseous local anaesthesia (Quicksleeper 5, an electronically controlled intra-osseous anaesthesia injection system) to children during general anaesthesia prior to the extraction of a first permanent molar (FPM) has an effect on immediate and later postoperative delirium in the child. Postoperative delirium will be assessed 5 min after spontaneous eye opening using a validated flowchart
Pre- and postoperative pain in the child (Visual Analogue Scale - VAS)
时间窗: Preoperative: upon arrival at the hospital Postoperative: after 120 minutes
to investigate whether the administration of intra-osseous local anaesthesia (Quicksleeper 5, an electronically controlled intra-osseous anaesthesia injection system) to children during general anaesthesia prior to the extraction of a first permanent molar (FPM) has an effect on immediate and later postoperative pain in the child. Pre-and postoperative pain will be assessed at a fixed time after the procedure (after 120 minutes) using the validated VAS (Visual Analogue Scale) scale. Upon arrival at the hospital, the preoperative VAS will be taken. The scale consists of a line of numbers from 0 (left side of the line) to 10 (right side of the line). The higher the number, the more pain, so a worse outcome.
Pre- and postoperative pain in the child (Face-Legs-Activity-Cry-Consolability Scale)
时间窗: Preoperative: arrival at the hospital, postoperative: after 10,30,60,120 minutes
to investigate whether the administration of intra-osseous local anaesthesia (Quicksleeper 5, an electronically controlled intra-osseous anaesthesia injection system) to children during general anaesthesia prior to the extraction of a first permanent molar (FPM) has an effect on immediate and later postoperative pain in the child. Pre-and postoperative pain will be assessed at fixed times after the procedure (after 10/30/60/120 minutes) using the validated FLACC (Face-Legs-Activity-Cry-Consolability Scale) scales. Upon arrival at the hospital, the preoperative FLACC will be taken. The scale consists of 5 scores assigned by an observer based on child's behavior/attitude. The sum of these determines the pain. 0 is no pain, 10 is intense pain. The higher the score, the outcome is worse.
Pre- and postoperative anxiety in the child (CFSS-DS - Children's Fear Survey Schedule - Dental Subscale)
时间窗: Preoperative: upon arrival at the hospital Postoperative: after 120 minutes
to investigate whether the administration of intra-osseous local anaesthesia (Quicksleeper 5, an electronically controlled intra-osseous anaesthesia injection system) to children during general anaesthesia prior to the extraction of a first permanent molar (FPM) has an effect on immediate and later postoperative anxiety in the child. Postoperative anxiety will be assessed at a fixed time after the procedure (after 120 minutes) using a validated scale (CFSS-DS - Children's Fear Survey Schedule - Dental Subscale). The scale consists of 15 questions with a score from 1 till 5. A score of 15 in total means no anxiety, a higher score means more dental anxiety/fear, so a worse outcome.
次要结局
- presence of postoperative side effects related to local anesthesia(10 minutes up to 24 hours 10, 30, 60, 120 minutes after waking up (VAS - Visual Analogue Scale, FLACC - Face, Legs, Activity, Cry and Consolability, CFSS-DS- Children's Fear Survey Schedule - Dental Subscale questionnaire). After 24 hours: QoR-15)