The impact of the caregiver’s voice on emergence delirium in children: A prospective randomized control trial

Introduction

 Emergence delirium (ED) is an acute brain dysfunction during recovery from general anesthesia. It can be complicated by varying levels of consciousness and encompasses disruptive behaviors that almost always require intervention during the postoperative period.

Pediatric emergence delirium (paedED)is seen most commonly in children between the ages of 2- 8 years and may present with purposelessness, disorientation, decreased awareness of surrounding, staring or averting of eyes from caregivers and inconsolability.

PaedED continues to be a matter of concern in perioperative care and its varied incidence (2%-80%) is influenced by a wide range of risk factors, including preoperative parental and child anxiety, use of volatile anesthetic, type of surgery and untreated pain.

Children experiencing ED are associated with an increased risk of injuring themselves, their caregivers and their surgical repair, displacing intravenous lines, catheters, drains. ED leads to increased length of stays and constant supervision in post-anesthesia care unit (PACU), which puts a strain on healthcare resourcesindicating the need for better preventive and curative measures. In addition, it was seen that children with PaedED were 1.43 times at greater risk of having long term maladaptive behavioral changes.

Pharmacological methods like alpha 2 agonists(dexmedetomidine), opioids, melatonin, midazolam, ketamine and magnesium, when used in conjunction with volatile anesthetics have been shown to reduce the incidence and severity of emergence delirium. However, children may experience side effects such as hypotension, bradycardia, sedation with the use of these medications.

Emergence delirium in children has also been addressed using non pharmacological approaches. Some of these methods include parental presence, cartoons, handheld video games during induction, and have proven to be comparable to medications in reducing the incidence of ED

Studies have shown that listening to a mother’s voice postoperatively reduces emergence delirium compared to those hearing a stranger’s voice, suggesting a comforting role of familiar voices.

However, since the mother may not always be present or the primary caregiver, we chose to examine the impact of the closest caregiver’s voice on emergence delirium.

Methodology:

 The children who fulfill the inclusion criteria and are posted for elective surgery will be screened for the study. Informed consent will be taken from the parent. For children aged 7-8 years, assent will be obtained in addition to the parental consent. We will explain the study in an age-appropriate language, using simple verbal explanations or visual aids (pictures and headphones).The child’s agreement will be documented on an assent form. For children between 2-6 years, formal assent is not required but we will explain the study in an age-appropriate manner to ensure the child’s comfort and to minimize distress. A thorough Pre-anesthetic checkup (PAC) will be done one day prior to the proposed surgery. The patient will be kept nil per oral for 6 hours pre operatively for solids, and 2 hours for clear fluids, as per existing fasting guidelines.

 On the day of the surgery, randomisation and voice recording will be done by an independent assessor who is an anaesthesiologist. The anaesthesiologist in the OT will be blinded to the group allocation and will perform the study. The caregiver and the anesthesiologist (independent assessor) will be asked to speak the following sentences in their usual tone of voice and in the language that is spoken/understood by the child. “Wake up (name of the child). Open your eyes, breathe well. Wake up, (name of the child) It is time to go home. Wake up (name of child).”

 The participants will be randomized to one of two groups with a 1:1 ratio-Group C participants will be made to listen to the recorded voice of the caregiver and Group A will be made to listen to the recorded voice of the

Anesthesiologist. The randomization will be done using the random number generator tool available on Google. In case an odd number is generated the participant will be part of Group A and if an even number is generated, the participant will be part of Group C.

 We will assess the preoperative anxiety in the child in the pre-op area using the modified Yale preoperative anxiety scale for children (m-YPAS). We calculate the m-YPAS score by dividing each domain score by the highest possible score (i.e., 6 for the “vocalizations” domain and 4 for all other items), add all of the produced values, divide by 4, and multiply by 100. This produces a score ranging from 22.92 to 100, with higher values indicating greater anxiety.

After entering the operating theatre, standard monitoring equipment (non-invasive arterial blood pressure, electrocardiography, heart rate, pulse oximetry and end tidal CO2) will be connected to the patient. Baseline recording will be noted.

 Premedication will be administered with Glycopyrrolate 10mcg/kg IV. Ondansetron 0.15mg/kg IV and midazolam 0.03 mg/kg IV. Anesthesia will be induced with Inj. Fentanyl 2mcg/kg. Propofol 2mg/kg IV. Atracurium(0.5 mg/kg IV)will be administered and ventilation will be done with a bag and mask for 3 minutes. This will be followed by direct laryngoscopy and intubation with an appropriate-sized Macintosh blade and endotracheal tube respectively. Anaesthesia will be maintained on 50% air-oxygen mixture and sevoflurane titrated and kept to MAC between 1.0 and 1.2. Regular intervals of Atracurium (0.1mg/kg IV) will be given to maintain neuromuscular blockade.In case of infra umblical surgeries, caudal analgesia with 0.25% Bupivacaine(1ml/kg) will be given.Intermittent Fentanyl boluses(0.5 mcg/kg) will be given for all other surgeries. Paracetamol 10mg/kg will also be given IV for all surgeries for analgesia.

 The recorded voice of the caregiver (Group C) or the anaesthesiologist( Group A) will be delivered through

noise cancelling headphones at the end of the surgery and will be repeated every 20 seconds until the patient

has entered the PACU. The volume will be set to a normal speech level and the patient will be stimulated to

wake up by lightly patting on the shoulder. No other stimulation is allowed.

 The effect of Atracurium will be reversed using Neostigmine (0.05 mg/kg IV) and Glycopyrrolate (10 mcg/kg IV) and the oral cavity secretions will be gently suctioned and the child will be extubated once the extubation criteria has been met.