Acupuncture management of pain and emergence agitation in children after bilateral myringotomy and tympanostomy tube insertion

Abstract

To further investigate the effect of acupuncture in postoperative pain and emergence agitation in children undergoing bilateral myringotomy and tympanostomy tube (BMT) placement.
BMT insertion surgery in children is routinely performed under general anesthesia and is associated with a high incidence of postoperative pain and agitation upon emergence from anesthesia. Various medications have been investigated to alleviate the pain and agitation, which have been accompanied by high incidence of adverse effects. In children, anecdotal reports suggest that acupuncture may offer postoperative analgesia.
This prospective randomized controlled trial is to evaluate the effectiveness of acupuncture to control pain and agitation after initial bilateral myringotomy tube placement in 60 nonpremedicated children. Acupuncture was applied at points LI-4 (he gu) and HT-7 (shen men) immediately after induction of anesthesia. A single-blinded assessor evaluated postoperative pain and agitation using CHEOPS and emergence agitation scale. Pain and agitation scores were significantly lower in the acupuncture group compared to those in the control group at the time of arrival in the post anesthesia care unit and during the subsequent 30 min.
Acupuncture treatment provided significant benefit in pain and agitation reduction. The median time to first postoperative analgesic (acetaminophen) administration was significantly shorter in the control group. The number of patients who required analgesia was considerably fewer in the acupuncture group than that in the control. No adverse effects related to acupuncture treatment were observed.
Our study suggests that acupuncture therapy may be effective in diminishing both pain and emergence agitation in children after BMT insertion without adverse effects.

Full text

Acupuncture management of pain and emergence
agitation in children after bilateral myringotomy
and tympanostomy tube insertion
YUAN-CHI LIN MD MPHMD MPH*, ROSALIE F. TASSONE MD MPHMD MPH*,
STEFAN JAHNG MDMD*, REZA RAHBAR MDMD†, ROBERT S.
HOLZMAN MDMD*, DAVID ZURAKOWSKI PPhDhD‡AND
NAVIL F. SETHNA MDMD*
Departments of *Anesthesiology, Perioperative and Pain Medicine and †Otorhinolarngology and
‡Director of Biostatistics, Department of Anesthesiology, Perioperative and Pain Medicine,
Children’s Hospital Boston, Harvard Medical School, Boston, MA, USA
Summary
Aim: To further investigate the effect of acupuncture in postoperative
pain and emergence agitation in children undergoing bilateral
myringotomy and tympanostomy tube (BMT) placement.
Background: BMTinsertionsurgeryinchildrenisroutinely performed under
general anesthesia and is associated with a high incidence of postoperative
pain and agitation upon emergence from anesthesia. Various medications
have been investigated to alleviate the pain and agitation, which have been
accompanied by high incidence of adverse effects. In children, anecdotal
reports suggest that acupuncture may offer postoperative analgesia.
Methods ⁄Materials: This prospective randomized controlled trial is to
evaluate the effectiveness of acupuncture to control pain and agitation
after initial bilateral myringotomy tube placement in 60 nonpremed-
icated children. Acupuncture was applied at points LI-4 (he gu) and
HT-7 (shen men) immediately after induction of anesthesia. A single-
blinded assessor evaluated postoperative pain and agitation using
CHEOPS and emergence agitation scale. Pain and agitation scores
were significantly lower in the acupuncture group compared to those
in the control group at the time of arrival in the post anesthesia care
unit and during the subsequent 30 min.
Results: Acupuncture treatment provided significant benefit in pain
and agitation reduction. The median time to first postoperative
analgesic (acetaminophen) administration was significantly shorter in
the control group. The number of patients who required analgesia was
considerably fewer in the acupuncture group than that in the control.
No adverse effects related to acupuncture treatment were observed.
Conclusion: Our study suggests that acupuncture therapy may be
effective in diminishing both pain and emergence agitation in children
after BMT insertion without adverse effects.
Keywords: pediatric acupuncture; pediatric pain; emergence agitation
Correspondence to: Y.-C. Lin, Medical Acupuncture Service, Department of Anesthesiology, Perioperative and Pain Medicine, Children’s
Hospital Boston, Harvard Medical School, 300 Longwood Avenue, Boston, MA 02115, USA (email: Yuan-chi.lin@childrens.harvard.edu).
Pediatric Anesthesia 2009 19: 1096–1101 doi:10.1111/j.1460-9592.2009.03129.x
1096 2009 Blackwell Publishing Ltd

Introduction
Bilateral myringotomy and tympanostomy tube
(BMT) placement is one of the most frequently
performed pediatric surgical procedure (1). The
procedure is brief and is commonly performed in
outpatient surgical units under general anesthesia. It
may be associated with the high incidence of pain
and emergence agitation (18–80%), often requiring
opioids and sedatives that may cause undesirable
side effects (2–4). Pharmacological agents, such as
acetaminophen, fentanyl, butorphanol, midazolam,
ketamine clonidine, and ketorolac, have been used
for the management of pain and emergence agita-
tion, have resulted in variable analgesic effectiveness
(50–80%), and have been shown to cause excessive
sleepiness (75%) and nausea and vomiting (4–33%)
(4–10). Acupuncture is reported to reduce pain and
produce sedation without causing such side effects.
We undertook this randomized controlled trial to
evaluate the effectiveness of acupuncture in reduc-
ing pain and emergence agitation in children under-
going BMT insertion surgery.
Methods
This trial was approved by the Institutional Review
Board at Children’s Hospital Boston. The inclusion
criteria were children classified under American
Society of Anesthesiologists physical status 1 or 2
and between the ages of 1 and 6 years who were
scheduled for BMT insertion surgery for the first
time. Exclusion criteria included the presence of
neurological diseases, developmental delay, or chil-
dren who had received analgesics and sedatives
within 36 h prior to surgery. After obtaining paren-
tal consent, patients were randomized into either the
acupuncture or the control group. Premedication
was not used in any of the patients. A standard
general anesthetic technique and monitoring were
used in all patients. Parental presence was allowed
during inhalational induction by mask with 70%
nitrous oxide in oxygen followed by incremental
increase in inspired sevoflurane. The concentration
of sevoflurane was increased gradually by 0.2%to
0.5%to achieve effective general anesthesia. Spon-
taneous ventilation was maintained, and the anes-
thetic depth was adjusted to each patient’s response
to surgical stimulation. Standard monitoring
included precordial stethoscope, electrocardiogram,
blood pressure, and percutaneous pulse oximetry.
Immediately after the induction of anesthesia and
prior to surgical stimulation, the patients in the
acupuncture group received acupuncture treatment.
A stainless steel acupuncture needle, 30 mm in
length and 0.18 mm in diameter (Serin Co, Shizuoka,
Japan), was used for the acupuncture. Acupuncture
treatment was applied bilaterally at acupuncture LI-
4 (he gu) and HT-7 (shen men) points (Figure 1) (11).
Each acupuncture needle was manually manipu-
lated for 10 s and kept in situ for a total time of
10 min. No electrical stimulation was applied. The
surgical intervention commenced immediately fol-
lowing the acupuncture treatment. The control
group received similar anesthetic management but
no acupuncture treatment.
During the procedure, the surgeon evaluated the
condition of the middle ear on a scale of 1–4 points:
1 = no fluid; 2 = serous fluid; 3 = pus; and 4 = thick
tenacious mucus (8). In the post anesthesia care unit
(PACU), a single-blinded observer evaluated levels
LI-4 (he gu)
HT-7
(shen men)
Figure 1
Acupuncture points: LI-4 (he gu) and HT-7 (shen men).
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of pain and agitation every 5 min until the patients
fulfilled the discharge criteria. Postoperative pain
was the primary outcome measure and was assessed
by the CHEOPS (12). Emergence agitation was
assessed on a 4-point scale: 1 = asleep, calm;
2 = mildly agitated but easily consolable; 3 = mod-
erately agitated or restless and inconsolable; and
4 = hysterical, crying inconsolably, or thrashing
(5,13).
When simple comfort measures such as the
presence of parents, physically holding the child,
or offering oral fluids did not console the patient;
oral acetaminophen 15 mgÆkg
)1
was administered. If
the patient remained inconsolable, an additional
dose of acetaminophen was given 30 min later. The
criteria for discharge were based on the 10-point
modified Aldrete Post Anesthesia Recovery Score
scale (14).
Statistical analysis
Age, weight, and surgical and anesthesia times were
compared between patients in the control and
acupuncture groups using the two-sample Student’s
t-test. The Pearson chi-square test was used to
compare the groups with respect to gender and the
distribution of right and left middle ear conditions.
Agitation and pain scores were assessed for normal-
ity using the Kolmogorov–Smirnov goodness-of-fit
test and were found to show significant departures
from a normal curve because of skewness (15).
Therefore, CHEOP pain scores (4–13 points) and
agitation scores (4-point scale) were compared with
each of seven postoperative time points (arrival
PACU, every 5 min through 30 min) using the
nonparametric Wilcoxon rank sum test (16). Box
plots were used to graphically represent the pain
and agitation data for the two groups at 5, 15, and
30 min to show the medians and interquartile ranges
(i.e., length of the box). Multivariate analysis of
variance was used to control for confounders
including age, weight, gender, surgical, and anes-
thesia duration to determine whether the effect of
acupuncture was independent of these variables.
The proportion of patients requiring additional
postoperative analgesia medications was compared
between the acupuncture and control groups
using Fisher’s exact test, and median time to
additional medications was compared using the
Mann–Whitney U-test. Statistical analysis was per-
formed using SPSSSPSS version 14.0 (SPSS, Inc., Chicago,
IL, USA). A conservative two-tailed value P< 0.01
was used as the criterion for statistical significance to
protect against false positive (Type I errors) because
of comparing the groups at multiple time points. A
power analysis indicated that the sample size of 30
patients in each group provided 80%power to
detect a difference of two points in CHEOP pain
scores and one point in agitation scores between the
control and acupuncture groups (version 7.0, nQuery
Advisor, Statistical Solutions, Saugus, MA, USA).
Statistical analysis was performed using SPSSSPSS
software (version 16.0, SPSS, Inc.).
Results
Sixty patients, 38 boys and 22 girls, with a mean age
2.2 ± 1.4 years were enrolled. There was no differ-
ence with respect to gender, age, weight, surgical
and anesthesia time, or the degree of middle ear
condition between patients who received acupunc-
ture treatment vs control (all P> 0.10, Table 1).
There were no postoperative complications related
to surgery, anesthesia, or acupuncture therapy.
Differences in postoperative CHEOP pain scores
were observed at arrival in PACU (P< 0.001) and at
each 5 min time point (all P< 0.01, Table 2). In
general, median pain scores were between 2 and 4
Table 1
Demographic characteristics, duration of surgery and anesthesia,
and middle ear conditions
Variable
Control
group
(n=30)
Acupuncture
group
(n=30) Pvalue
Age, years 2.0 ± 1.3 2.4 ± 1.6 0.36
Weight, kg 12.7 ± 3.3 14.2 ± 4.9 0.18
Gender (M ⁄F) 19 ⁄11 19 ⁄11 1.00
Duration of surgery, min 8.7 ± 3.2 9.9 ± 4.4 0.24
Duration of anesthesia, min 24.7 ± 6.3 23.7 ± 8.1 0.58
Right middle ear, number (%) 0.83
1 7 (23) 9 (30)
2 13 (43) 12 (40)
3 5 (17) 3 (10)
4 5 (17) 6 (20)
Left middle ear, number (%) 0.86
1 6 (20) 5 (17)
2 12 (40) 15 (50)
3 5 (17) 5 (17)
4 7 (23) 5 (17)
Continuous data are mean ± SDSD.
1098 Y.-C. LIN ET AL.
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points lower in the acupuncture group and showed
significantly lower distributions at the seven time
points. Figure 2 illustrates the differences in postop-
erative pain scores between the two groups using
box plots at 5, 15, and 30 min.
Differences in postoperative agitation scores were
observed at arrival in PACU (P< 0.001) and at each
5 min time point (all P< 0.01, Table 3). In general,
median agitation scores were between 1 and 2 points
lower in the acupuncture group and showed signif-
icantly lower distributions at the seven time points.
Figure 3 illustrates the differences in postoperative
agitation scores between the two groups using box
plots at 5, 15, and 30 min.
Multivariate analysis of variance revealed no
other significant predictors of postoperative pain or
agitation scores and confirmed that acupuncture
treatment provided significant benefit in pain and
agitation reduction independent of age, weight,
gender, surgical and anesthesia duration, or middle
ear condition.
None of the 60 patients experienced postoperative
nausea or vomiting. Although there was no difference
in the duration of PACU stay, the need for postoper-
ative oral acetaminophen was significantly lower in
the acupuncture group (57%) when compared to the
Table 2
Postoperative pain scores during recovery for control and acu-
puncture groups
Time point
CHEOPS pain score
Pvalue*
Control
group
(n=30)
Acupuncture
group
(n=30)
Arrival post
anesthesia care unit
11 (6–13) 7 (4–12) <0.001
5 min 11 (6–13) 7 (4–12) <0.001
10 min 10 (6–13) 7 (4–12) 0.002
15 min 9 (4–13) 6 (4–12) 0.002
20 min 9 (5–12) 6 (4–11) 0.005
25 min 8 (4–12) 6 (4–11) <0.001
30 min 8 (5–12) 6 (4–9) <0.001
Data are median score with ranges shown in parentheses.
CHEOPS, Children’s Hospital of Eastern Ontario Pain Scale (4–13
points).
*Significant difference between the groups at each time point
(Mann–Whitney U-tests).
13
10
11
12 Acupuncture
Control group
7
8
9
CHEOP pain score
5
6
7
*
**
Postoperative assessment (minutes)
4
515 30
Figure 2
The differences in postoperative pain scores between the two
groups using box plots at 5, 15, and 30 min.
Table 3
Postoperative agitation scores during recovery for control and
acupuncture groups
Time point
Agitation score
Pvalue*
Control
group
(n=30)
Acupuncture
group
(n=30)
Arrival post
anesthesia care unit
3 (1–4) 1 (1–3) <0.001
5 min 3 (1–4) 1 (1–3) <0.001
10 min 3 (1–4) 1.5 (1–4) 0.007
15 min 3 (1–4) 1 (1–4) 0.003
20 min 2.5 (1–4) 1 (1–3) 0.004
25 min 2 (1–4) 1 (1–2) <0.001
30 min 2 (1–4) 1 (1–2) <0.001
Data are median score with ranges shown in parentheses.
*Significant difference between the groups at each time point
(Mann–Whitney U-tests).
4
3
Control group
Acupuncture
2
Agitation score
1***
Postoperative assessment (minutes)
5 15 30
Figure 3
The differences in postoperative agitation scores between the two
groups using box plots at 5, 15, and 30 min.
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control group (87%)(P= 0.02, Fisher’s exact test).
Median time to postoperative oral acetaminophen
was significantly shorter in the control group (6 h vs
17 h, P< 0.01, Mann–Whitney U-test).
Discussion
Pain following BMT insertion is common; with
50-70%of children requiring analgesics in the
immediate postoperative period (9,13). Several phar-
macological agents have been studied to reduce
postoperative pain and emergence agitation after
BMT insertion in randomized blinded controlled
trials. While administration of intranasal fentanyl
2 mcgÆkg
)1
with various inhaled agents produced a
reduction in agitation scores relative to controls,
fentanyl was associated with an increased incidence
of postoperative vomiting (5,17). Administration of
transnasal butorphanol (25 mcgÆkg
)1
) also signifi-
cantly reduces postoperative pain and agitation
scores, decreases the frequency of occurrence com-
pared to controls, and does not delay discharge time.
However, increased sedation is associated with its
use (6). Administration of intravenous (8) or intra-
muscular (9) ketorolac 1 mgÆkg
)1
following midazo-
lam premedication also markedly diminishes
emergence agitation and ⁄or pain behavior. Postop-
erative analgesia following intramuscular ketorolac
was similar to nasal butorphanol (25 mcgÆkg
)1
),
produced significantly better analgesia than oral
acetaminophen with codeine (1 mgÆkg
)1
), and the
lowest rate of vomiting (3%) (9). The use of intra-
venous clonidine (2 mcgÆkg
)1
) after anesthetic
induction for minor otologic and laser procedures
diminished emergence agitation with significant
sedation and delayed time to discharge (4). Our
study demonstrates that acupuncture can effectively
reduce the pain and emergence agitation following
BMT insertion surgery in children without any
adverse effects.
Emergence agitation is a short-lived, but a trou-
blesome clinical event. There are no effective
preventive strategies (18). Emergence agitation can
burden health care providers, increase family dis-
tress, expose the child to potential injury, and delay
recovery after anesthesia (19). Emergence agitation
occurs after 18–80%of children undergoing general
anesthetics and may also follow brief inhaled
anesthesia and nonpainful procedures (2–4). The
mechanism of agitation following general anesthesia
is unclear. There is no universal scale to assess
postoperative agitation that is developmentally and
psychometrically valid for evaluation of the children
of different ages (19). Therefore, studies evaluating
postoperative agitation have used various agitation
scales, including pain or anxiety assessment scales,
making comparisons of therapeutic interventions
among the studies difficult.
In adults, stimulation of the acupuncture point,
LI-4 (he gu), is shown to increase activity in the
periaqueductal gray and somatosensory cortex dur-
ing functional MRI study (20), and to relieve head-
ache and facial and ear pain (11). The second
acupuncture point used in this study, HT-7 (shen
men), is reported to reduce stress and agitation in
adult subjects (11). In animal model, activation of
acupuncture point HT-7 (shen men) produced a
significant reduction in the behavioral hyperactivity
associated with morphine tolerance through inhibi-
tion of central release of GABA
B
modulating dopa-
mine (21). In a study of health care personnel,
utilizing bilateral HT-7 (shen men) acupuncture
treatment once a week for 4 weeks produced
marked reduction in workplace-related psychologi-
cal stress in 16 out of 17 (94%) subjects (22).
In conclusion, acupuncture therapy at bilateral LI-
4 (he gu) and HT-7 (shen men) markedly reduces the
severity of postoperative pain and emergence agita-
tion in children after sevoflurane and nitrous oxide
anesthesia for BMT insertion without adverse
events. Further studies are needed to evaluate the
long-term effect of acupuncture therapy beyond the
immediate recovery time and compare its efficacy
and adverse effects to analgesic regimens in current
use for management of pain and agitation in chil-
dren undergoing BMT insertion.
Acknowledgements
The authors thank Yue-Pang Mok, MD (Ohio Pain
Services, Inc.) for his advice on selection of utilized
acupuncture points. The authors also express sincere
gratitude to the staff in the Department of Anesthe-
siology, Perioperative and Pain Medicine, the
Department of Otolaryngology, and Post Anesthesia
Care Unit of Children’s Hospital, Boston, for the care
they provided to the patients who participated in
this study.
1100 Y.-C. LIN ET AL.
2009 Blackwell Publishing Ltd, Pediatric Anesthesia,19, 1096–1101

References
1 Boston M, McCook J, Burke B et al. Incidence of and risk fac-
tors for additional tympanostomy tube insertion in children.
Arch Otolaryngol Head Neck Surg 2003; 129: 293–296.
2 Voepel-Lewis T, Malviya S, Tait AR. A prospective cohort
study of emergence agitation in the pediatric postanesthesia
care unit. Anesth Analg 2003; 96: 1625–1630.
3 Cravero J, Surgenor S, Whalen K. Emergence agitation in
paediatric patients after sevoflurane anaesthesia and no sur-
gery: a comparison with halothane. Paediatr Anaesth 2000; 10:
419–424.
4 Malviya S, Voepel-Lewis T, Ramamurthi RJ et al. Clonidine for
the prevention of emergence agitation in young children:
efficacy and recovery profile. Pediatr Anesth 2006; 16: 554–559.
5 Finkel JC, Cohen IT, Hannallah RS et al. The effect of intranasal
fentanyl on the emergence characteristics after sevoflurane
anesthesia in children undergoing surgery for bilateral my-
ringotomy tube placement. Anesth Analg 2001; 92: 1164–1168.
6 Bennie RE, Boehringer LA, Dierdorf SF et al. Transnasal but-
orphanol is effective for postoperative pain relief in children
undergoing myringotomy. Anesthesiology 1998; 89: 385–390.
7 Bean-Lijewski JD, Stinson JC. Acetaminophen or ketorolac for
post myringotomy pain in children? A prospective, double-
blinded comparison Paediatr Anaesth 1997; 7: 131–137.
8 Davis PJ, Greenberg JA, Gendelman M et al. Recovery char-
acteristics of sevoflurane and halothane in preschool-aged
children undergoing bilateral myringotomy and pressure
equalization tube insertion. Anesth Analg 1999; 88: 34–38.
9 Pappas AL, Fluder EM, Creech S et al. Postoperative analgesia
in children undergoing myringotomy and placement equal-
ization tubes in ambulatory surgery. Anesth Analg 2003; 96:
1621–1624.
10 Abu-Shahwan I, Chowdary K. Ketamine is effective in
decreasing the incidence of emergence agitation in children
undergoing dental repair under sevoflurane general anesthe-
sia. Pediatr Anesth 2007; 17: 846–850.
11 Huang W-S. Acupuncture Science. Taipei, London: Cheng
Chung Book Co, Ltd., 1985.
12 McGrath P, Johnson G, Goodman JT. CHEOPS: a behavioral
scale for rating postoperative pain in children. In: Fields H,
Dubner R, Cervero F, eds. Proceedings of the Fourth World
Congress on Pain Advances in Pain Research and Therapy. New
York: Raven Press, 1985: pp. 395–402.
13 Watcha MF, Ramirez-Ruiz M, White PF et al. Perioperative
effects of oral ketorolac and acetaminophen in children
undergoing bilateral myringotomy. Can J Anaesth 1992; 39:
649–654.
14 Aldrete JA. The post-anesthesia recovery score revisited. J Clin
Anesth 1995; 7: 89–91.
15 Riffenburgh R Statistics in Medicine, 2nd edn. St Louis,
Missouri: Elsevier, 2006: pp. 370–386.
16 Pagano M, Gauvreau K. Principles of Biostatistics. Pacific Grove,
CA: Duxbury Press 2000: pp. 302–322.
17 Galinkin JL, Fazi LM, Cuy RM et al. Use of intranasal fentanyl
in children undergoing myringotomy and tube placement
during halothane and sevoflurane anesthesia. Anesthesiology
2000; 93: 1378–1383.
18 Vlajkovic GP, Sindjelic RP. Emergence delirium in children:
many questions, few answers. Anesth Analg 2007; 104: 84–91.
19 Cravero JP. Emergence agitation: time for heavy lifting. J Clin
Anesth 2005; 17: 491–493.
20 Liu WC, Feldman SC, Cook DB et al. fMRI study of acupunc-
ture-induced periaqueductal gray activity in humans. Neuro-
report 2004; 12: 1937–1940.
21 Kim MR, Kim SJ, Lyu YS et al. Effect of acupuncture on
behavioral hyperactivity and dopamine release in the nucleus
accumbens in rats sensitized to morphine. Neurosci Lett 2005;
1: 17–21.
22 Chan J, Briscomb D, Waterhouse E et al. An uncontrolled pilot
study of HT7 for ‘stress’. Acupunct Med. 2002; 20: 74–77.
Accepted 30 June 2009
ACUPUNCTURE FOR PAIN AND EMERGENCE AGITATION 1101
2009 Blackwell Publishing Ltd, Pediatric Anesthesia,19, 1096–1101