Acupuncture for the Prevention of Emergence Delirium in Children Undergoing Myringotomy Tube Placement

NCT02383004 | Completed DMC

• 1 other identifier: IRB00010770
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delirium; Psychomotor Agitation

Keywords

myringotomy tubes; acupuncture; emergence delirium; pediatrics; general anesthesia

Outcome Measures

Primary Outcomes (1)

• Pediatric Anesthesia Emergence Delirium (PAED) Score

  The start of awakening will be indicated by the time point of first observed, sustained eye opening. In the Post-Anesthesia Care Unit (PACU) and Day Stay units, an observer will evaluate the patient at four time points: time of awakening, 5 minutes after awakening, 10 minutes after awakening and 15 minutes after awakening. The observer will use the Pediatric Anesthesia Emergence Delirium (PAED) evaluation tool evaluate each child for emergence delirium.

  0-15 minutes after awakening from general anesthesia in the recovery room

Secondary Outcomes (2)

• Behavior Disturbances on Post-Operative Day 1 (POD1)

  24 hours

• Behavior Disturbances one week after surgery (POD 7)

  7 days

Study Arms (2)

Acupuncture

EXPERIMENTAL

Same premedication, induction and maintenance protocol as the No Acupuncture (Standard of Care) group. The intervention will be placement of 4 acupuncture needles. The needles will be placed after inhalational 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.

Other: Acupuncture

No Acupuncture (Standard of Care)

NO INTERVENTION

If needed, the patient will receive a standard does of oral midazolam (0.5 mg /kg or less, up to 15mg) plus acetaminophen 12.5 mg/kg (V group). If the patient does not require premedication with midazolam, oral acetaminophen 12.5mg/kg will be given alone (NV group). Induction of anesthesia by mask ventilation with sevoflurane in 50% nitrous oxide mixed with 50% oxygen. Sevoflurane will be incrementally titrated from 0% up to 8%. Nitrous oxide will be discontinued after induction. Anesthesia will be maintained with sevoflurane in an oxygen/air mixture. Sevoflurane concentration will be titrated to maintain the adequate depth of anesthesia. Prior to leaving the operating room, a dose of ketorolac 0.5mg/kg will be given intramuscularly.

Interventions

Acupuncture OTHER

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.

Acupuncture

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children ages 1 - 6 years old with ASA physical status of 1-3
• scheduled for unilateral or bilateral myringotomy tube placement only.

You may not qualify if:

• use of mood altering medications, including anti-epileptic medications.
• genetic abnormalities, including Trisomy 21 (Down syndrome).
• children scheduled for additional surgical procedures to be done in conjunction with myringotomy tube placement.
• Patients scheduled for an overnight admission post operatively.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

Location

Related Publications (5)

• van Dongen TM, van der Heijden GJ, Freling HG, Venekamp RP, Schilder AG. Parent-reported otorrhea in children with tympanostomy tubes: incidence and predictors. PLoS One. 2013 Jul 12;8(7):e69062. doi: 10.1371/journal.pone.0069062. Print 2013.

  PMID: 23874870 RESULT

• Isik B, Arslan M, Tunga AD, Kurtipek O. Dexmedetomidine decreases emergence agitation in pediatric patients after sevoflurane anesthesia without surgery. Paediatr Anaesth. 2006 Jul;16(7):748-53. doi: 10.1111/j.1460-9592.2006.01845.x.

  PMID: 16879517 RESULT

• Bajwa SA, Costi D, Cyna AM. A comparison of emergence delirium scales following general anesthesia in children. Paediatr Anaesth. 2010 Aug;20(8):704-11. doi: 10.1111/j.1460-9592.2010.03328.x.

  PMID: 20497353 RESULT

• Lin YC, Tassone RF, Jahng S, Rahbar R, Holzman RS, Zurakowski D, Sethna NF. Acupuncture management of pain and emergence agitation in children after bilateral myringotomy and tympanostomy tube insertion. Paediatr Anaesth. 2009 Nov;19(11):1096-101. doi: 10.1111/j.1460-9592.2009.03129.x. Epub 2009 Aug 26.

  PMID: 19709377 RESULT

• Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.

  PMID: 15114210 RESULT

MeSH Terms

Conditions

Delirium; Psychomotor Agitation; Emergence Delirium

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Christine S Martin, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 9, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 18, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)