Acupuncture for the Prevention of Emergence Delirium in Children Undergoing Myringotomy Tube Placement
Condition: Delirium; Psychomotor Agitation
MeSH terms: Delirium; Psychomotor Agitation; Emergence Delirium
Study type: Interventional

Summary: 
      Myringotomy tube placement is one of the most commonly performed operations in children.
      Emergence delirium after such procedures is common. During emergence delirium children can
      become both a danger to themselves and others around them, including family members and
      hospital staff.

      The primary objective of this study is to determine if acupuncture, when used in combination
      with standard anesthetic management, decreases the incidence of emergence delirium in
      pediatric patients following myringotomy tube placement. Patients with and without
      premedication of midazolam will be included. A secondary objective of this study is to
      determine our institution's actual incidence of emergence delirium for this operation using a
      validated scale, the Pediatric Anesthesia Emergence Delirium (PAED) scale. We will also
      compare rates of emergence delirium in patients that received a premedication of midazolam
      versus (V) those that did not (NV).

      This is a randomized double-blinded trial. We will enroll 100 children aged 1-6 years old.
      Premedication with midazolam will be decided by the anesthesiologist. If needed, the patient
      will receive a standard does of oral midazolam plus acetaminophen (V). If the patient does
      not require premedication with midazolam, oral acetaminophen will be given alone (NV).

      Patients will then be randomized to receive either acupuncture with standard general
      anesthesia care (A) or to receive standard anesthetic care alone (S). Patients, their family
      members and recovery registered nurses (RNs) will not know if acupuncture was performed.
      Intraoperative anesthetic techniques will be standardized and include inhaled inductions with
      nitrous oxide and sevoflurane. Anesthesia maintenance will be inhaled sevoflurane and the
      usual pain medication ketorolac will be given intramuscularly prior to emergence. Acupuncture
      needles will be placed after anesthesia induction and removed prior to leaving the operating
      room. A total of 4 needles will be placed, one in each wrist at the Heart 7 (HT7) point and
      one in each ear at the Shen Men point. The needles will be inserted bilaterally to a depth of
      1.8 mm.

      In the PACU, a blinded study observer will evaluate the patient at four time points using the
      PAED scale: time of awakening and 5, 10 & 15 minutes after awakening. Follow up phone calls
      will be made one day and one week after surgery. Families will be asked about behavior after
      discharge, sleep and bed-wetting.
    

Detailed description: 
      Myringotomy tube placement is one of the most commonly performed operations in children, with
      almost 700,000 completed in the United States each year 1. Common anesthetic management of
      these cases includes inhalational anesthesia and no intravenous line placement. Sevoflurane
      is the inhalational agent used most commonly for induction and maintenance of these patients.
      Emergence delirium after sevoflurane maintenance is common. In a study of children receiving
      sevoflurane-based anesthetic for MRIs, 47.6% of participants had emergence agitation 2. In a
      comparison of different emergence delirium scales, Bajwa and colleagues detected emergence
      delirium in 32% of subjects using the Pediatric Anesthesia Emergence Delirium (PAED) scale 3.
      Emergence delirium can be distressing for both children and their caregivers. During
      emergence delirium children can become both a danger to themselves and others around them,
      including family members and hospital staff. Emergence delirium can also delay discharge from
      the post-operative care unit (PACU).

      There has been some published evidence that intraoperative acupuncture can decrease the
      incidence of post-operative delirium. One study enrolled 60 children undergoing bilateral ear
      tube placement and randomized half of the patients to receive acupuncture at points LI-4 (he
      gu) and HT-7 (shen men). The acupuncture group had a lower incidence of emergence agitation
      than the control group at time of arrival in the PACU and during the following 30 minutes 4.
      This study did not include patients that had received pre-medication with midazolam. It also
      did not use a validated assessment for emergence delirium in children.

      A small retrospective review of 12 children that received acupuncture found that 83% did not
      show signs of emergence delirium. These patients had needling at 3 locations (SP 6, HT 7, Liv
      3) and magnets placed at the ear shen men area. The anesthetic technique used for these
      patients was not standardized and there was no comparison group.

      The primary objective of this study is to determine if acupuncture, when used in combination
      with standard anesthetic management, decreases the incidence of emergence delirium in
      pediatric patients following myringotomy tube placement. Patients with and without
      premedication of midazolam will be included as it is common that children receive sedating
      medications to facilitate separation from their caregivers.

      A secondary objective of this study is to determine our institution's actual incidence of
      emergence delirium after this operation. We can also compare rates of emergence delirium with
      or without premedication of midazolam. Emergence delirium will be evaluated using a validated
      pediatric delirium scale. The Pediatric Anesthesia Emergence Delirium (PAED) scale has been
      tested for reliability and validity in 50 children 5.

      Study Design We plan to explore this question with a randomized double blinded trial of
      acupuncture in children who are undergoing myringotomy tube placement. Patients will be
      randomized to receive either acupuncture immediately after anesthesia induction (A) or to
      receive standard anesthetic care only (S). Patients, their family members and recovery
      registered nurses (RNs) will not know if acupuncture was performed. The researchers observing
      the patients in the PACU will also be blinded to whether or not the subject received
      acupuncture. Intraoperative anesthetic techniques will be standardized, including
      administering the usual pain medication of ketorolac 0.5mg/kg given intramuscularly to each
      patient prior to emergence. Needles will be placed after anesthesia induction and removed
      prior to leaving the operating room. A total of 4 needles will be placed, one in each wrist
      at the HT7 point and one in each ear at the shen men point. Emergence delirium will be
      assessed with the Pediatric Anesthesia Emergence Delirium (PAED) scale. A follow up phone
      call will be made on the first post-operative day (POD #1). We will assess continued
      emergence delirium after discharge from the PACU, as well as a brief assessment on sleeping
      patterns the night after surgery. A second follow-up phone call will be made one week after
      surgery. During that call, we will ask about the child's behavior and sleep patterns since
      the time of surgery.

      We do not know our institution's actual incidence of emergence delirium for this operation.
      We will assume it to be 25% as suggested by the literature. We do not know the effects of
      pre-medication with midazolam on the incidence of emergence delirium. We will assume a
      standard deviation of 4, a value consistent with the current published literature. By
      enrolling 100 subjects we can detect a difference of scores of at least 2.5 points. This
      enrollment will give us 80% power with an alpha of 0.05. Since the distribution of scores
      won't be normal, this enrollment target also includes a 15% increase to allow for a
      non-parametric distribution of results. Group (A) and group (S) will each have 50 children.
    

Intervention name(s): Acupuncture
Intervention type(s): Other
Intervention description(s): If the child is to receive acupuncture, the sites will be cleaned with an alcohol wipe and acupuncture will be performed using a Seirin pionex press needles. A needle will be placed in the Shen Men points of each ear. Needles will also be placed at the left and right Heart 7 (HT-7) point. This acupuncture point is located on the ulnar side of the anterior carpal region, on the palmer crease of the wrist and radial to pisiform bone. The needles will be inserted bilaterally to a depth of 1.8 mm. Needles will not be inserted at a site of active infection or skin breakdown. Needles will remain for the duration of the operation. The needles will be removed before leaving the operating room.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: myringotomy tubes; acupuncture; emergence delirium; pediatrics; general anesthesia