Int. J. Oral Maxillofac. Surg.

2005; 34: 281–286

doi:10.1016/j.ijom.2004.05.006, available online at http://www.sciencedirect.com

Clinical Paper
Oral Surgery
A. J. van der Westhuijzen1,
A randomized observer blind P. J. Becker2, J. Morkel1,
J. A. Roelse3
1
Department of Maxillo-facial and Oral

comparison of bilateral facial ice Surgery, Faculty of Dentistry, University of

Stellenbosch, South Africa; 2Biostatistics Unit,
Medical Research Council, Pretoria, South

pack therapy with no ice therapy Africa; 3Division of Anaesthesia, Faculty of

Dentistry, University of Stellenbosch, South
Africa

following third molar surgery

A. J. van der Westhuijzen, P. J. Becker, J. Morkel, J. A. Roelse:A randomized
observer blind comparison of bilateral facial ice pack therapy with no ice therapy
following third molar surgery. Int. J. Oral Maxillofac. Surg. 2005; 34: 281–286.
# 2004 International Association of Oral and Maxillofacial Surgeons.
Published by Elsevier Ltd. All rights reserved.

Abstract. This study compares the efficacy of Tecnol1 bilateral facial ice packs
with no cold therapy in reducing pain, swelling and trismus during the first 24 h
following third molar surgery.
Sixty patients requiring general anaesthesia for removal of bilateral, impacted
third molar teeth were included and randomly assigned to one of two treatment
groups. One group received Tecnol1 bilateral facial ice packs following
surgery, while a control group received no form of cold therapy. Facial ice
packs were applied in the recovery room within 15 min of the end surgery and
patients were asked to use the ice packs continuously for the next 24 h. Surgical
and anaesthetic techniques as well as pharmacological regimens were
standardized.
Key words: cryotherapy; ice therapy; facial ice
Postoperative pain levels were compared hourly, for 4 h, then on the evening of
packs; third molar surgery; dento-alveolar
surgery and the following morning. Facial swelling and trismus were compared surgery.
preoperatively and 24 h postoperatively.
No statistically significant difference was found between the two treatment Accepted for publication 4 May 2004
groups with respect to pain, facial swelling or trismus. Available online 19 July 2004

Cryotherapy or cold therapy is the local
or systemic application of cold for ther-
apeutic purposes and has been in use
since at least the time of Hippocrates23.
Local cold application is used to control
inflammation, pain, and edema; to
reduce spasticity; and to facilitate move-
ment4,23. Despite the frequent use of
cooling in orthopaedic rehabilitation and
physiotherapy, as evidenced by the
plethora of reports in the literature, there
is a paucity of scientific evidence in the
oral and maxillofacial surgery literature6
0901-5027/030281+06 $30.00/0
to justify treatment that is largely
applied in an empirical manner.
This study was performed to compare
the efficacy of bilateral facial ice ther-
apy with no ice therapy during the first
24 h following surgery, using an obser-
ver blind randomized experimental
design. Our hypothesis was that cold
therapy, applied by means of facial ice
packs, following third molar surgery,
provided postoperative control of facial
swelling, pain and trismus, that would
be superior to no ice application.
# 2004 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.
Tecnol1 bilateral facial ice packs,
produced by Tecnol Inc., Fort Worth,
TX, were selected for use in this study.
According to the manufacturer’s infor-
mation, it is a comfortable self-con-
tained product, that was designed to
provide up to 2 h of stay dry cold ther-
apy for relieve of pain and swelling that
resulted from oral surgery or other max-
illofacial procedures.
Other forms of applying cold therapy
to the facial area include chemical
packs, gel packs, and rubber ice bags as
282 van der Westhuijzen et al.
well as improvised items such as plastic
bags and gloves filled with ice.
Materials and methods
Outpatients between 18 and 40 years of
age who attended the dental teaching hos-
pital of the University of Stellenbosch
and who required surgical removal of
bilateral impacted mandibular third molar
teeth, with or without the concomitant
surgical removal of maxillary third molars
under general anaesthesia were eligible
for inclusion in this study.
Sixty patients were enrolled into two
treatment groups. At the 0.05 level of
significance and with a power of 90%, a
sample of 27 patients per group was
required to detect a 1.5 mm difference
in swelling between the groups, that is,
15% of 10-mm expected maximum
swelling. A sample of 27 patients per
group was required to detect a 15% dif-
ference in pain between the two groups
on a visual analogue scale, and a sample
of 26 patients per group was required to
detect a difference of 3.5 mm in mouth-
opening ability between the two groups.
Standard deviations of 1.67 (range/
6 ¼ 10/6), 16.7 (range/6) and 3.75 (nor-
mal range/4 ¼ 15/4) were used respec-
tively for swelling, pain and mouth-
opening ability.
The study was approved by the local
ethics committee and before entry into
the study, written informed consent was
obtained from each participant. Only
patients able to express and record their
pain accurately were included.
Before participation in this study, full
medical histories were obtained from all
patients, and all were physically exam-
ined. Patients with a history of unusual
responses to cold, with known cold intol-
erance or Raynaud’s phenomenon were
excluded from the study, as were patients
with, renal or hepatic disease, blood dys-
crasia, previous or present gastric ulcers,
heart disease, or patients with know
hypersensitivities, allergies, or idiosyn-
cratic reactions to any of the standardized
medications. Female patients were
excluded if they were pregnant or lactat-
ing. In addition, any patient being treated
with non-steroidal anti-inflammatory
agents, antibiotic therapy, lithium ther-
apy, anti-hypertensives or who had taken
any analgesics or anti-inflammatory
agents within a 24-h period before sur-
gery was excluded from the study.
The random allocation of patients to
the two treatment groups ensured that
patient and treatment variables such as
age, sex, weight, race, preoperative pain,
anaesthetist, surgeon, and degree of sur-
gical difficulty were uniformly distribu-
ted between the two treatment groups.
Anaesthetic management
All patients were treated as outpatients
and discharged no sooner than 4 h post-
operatively. No patient received antie-
metic, analgesic or anti-inflammatory
drugs, other than the standardized medi-
cation at any time.
No premedication was given. Anaes-
thesia was induced with Diprivan 2 mg/
kg. Nasotracheal intubation was facili-
tated with 0,1 mg/kg vecuronium given
intravenously. For mechanical ventilation
0.3 mg/kg alcuronium was given. Nitrous
oxide 60% in oxygen and isoflurane were
used for maintenance of anaesthesia.
The electrocardiograph, peripheral
pulse, arterial oxygen saturation and
arterial pressure were monitored con-
tinuously throughout the anaesthetic
whilst a capnograph was used to mea-
sure end-tidal carbon dioxide and to
ensure normo ventilation.
Anti-inflammatory and analgesic regimen
The peri-operative analgesic and anti-
inflammatory treatment was standardized
for all patients. A compound in capsular
form, each containing ibuprofen
(200 mg), paracetamol (250 mg), and
codeine phosphate (10 mg) was used. All
patients received 2 capsules with no more
than 10 ml H2O  30 min prior to sur-
gery and continued with two capsules
every 6 h for the first 24 h following sur-
gery, when they were seen for review,
and only then were they advised to taper
analgesic consumption as required. Medi-
cation times were recorded in the patient
self-assessment diary to ensure and check
compliance. One Tramadol 50 mg capsule
was provided as escape analgesia to be
used for unbearable pain only. Escape
analgesic consumption was recorded for
comparison between the two groups.
Standardised surgical technique
Seven surgeons participated in this
study. They rigidly adhered to a standar-
dized surgical technique of mandibular
and maxillary scalpel incisions, followed
by raising full mucoperiosteal flaps
before removal of mandibular and max-
illary third molars. In cases where max-
illary third molar delivery was possible
by direct elevation this was done.
When bone removal or odontectomy
was required, a drill and rosehead bur
kept under a continuous spray of sterile
saline solution was used. Tooth delivery
was followed by meticulous irrigation of
the surgical area with sterile saline solu-
tion to eliminate debris. The flap was
repositioned and the wound sutured with
a continuous mattress suture using 4-0
braided Polyglactin 910 sutures and an
atraumatic needle. No infiltration with
local anaesthetic was allowed peri-
operatively.
In order to assess and compare the
surgical difficulty and extent of surgical
trauma between the two study groups,
impactions were categorized into four
groups, i.e. partial or complete soft tis-
sue impactions and partial or complete
bone impactions.
Perioperative antimicrobial therapy
was standardized for all patients. Chlor-
hexidine gluconate 0.2% mouthwashes
were prescribed twice daily for all
patients. All operations were performed
in the morning and completed before
noon.
Study design
One study group had Tecnol1 bilateral
facial ice packs (Tecnol, Inc., Fort
Worth, TX) fitted in the recovery room
within 15 min following surgery. These
were fixed securely over the patient’s
heads with the ice-cube filled pouches in
contact with the cheeks in accordance
with the manufacturer’s directions.
Patients were instructed to replace the
ice-cubes in the pouches when the ice
had thawed and cooling became ineffec-
tive. The control group received no form
of cold therapy and patients in this
group were not alerted to the use of cold
therapy, but were asked at the time of
review, whether any self administered
cold therapy had been applied.
The bilateral facial ice pack consists
of two ice packs bonded together with a
strong Teclin strap that can be posi-
tioned across the crown of the head and
is secured with a Velcro strap. The ice
packs are lined with puncture-resistant
vinyl which prevents leakage, a middle
layer of polyester-rayon blended mate-
rial which serves to insulate the pack
and allow a proper level of cold transfer
and also to absorb and wick away con-
densation to keep the pack dry. The
outer layer of the ice pack, in contact
with the patient’s skin, consists of non-
irritating soft Teclin polyester. The
packs are ultrasonically sealed to pre-
vent leakage and have a plastic clip to
make opening and filling of pouches
with ice simple and convenient.

The pouches were filled with ice
cubes and repeatedly refilled when the
ice had thawed for more prolonged cold
therapy. Patients were asked to use the
ice packs continuously and sleep with
the ice packs on the face during the first
24 h following surgery. In order to check
and evaluate compliance, the exact times
that the ice packs were on or off the
face during the study period were
recorded in the self-assessment diaries.
Patients were instructed to rate and to
record pain intensity on a continuous
10-cm visual analogue scale, in which 0
represented no pain and 10 equalled the
worst pain imaginable. Pain severity, if
any, was recorded by the patient after
admission and before surgery on the
morning of the operation, and then at
each of the first 4 h after the end of the
anaesthetic with the assistance of a
trained nurse observer. On the evening
of surgery, patients recorded pain sever-
ity between 21:00 and 22:00 h, and
again between 07:00 and 08:00 h on the
morning following surgery.
Facial swelling was recorded in milli-
metres with Vernier-calibrated sliding
pointers attached to the horizontal exten-
sions of a modified bite-fork/facebow
appliance. The sliding pointers were
adjusted until they made contact with
the cheeks over the position of the third
molars. A thermoplastic impression
recorded in centric occlusion ensured
accurate repositioning at subsequent vis-
its of the sliding pointers over the area
of maximal swelling.
Studies by HOLLAND12 have shown
that swelling after third molar surgery
occurred symmetrically around the slid-
ing pointer provided it was accurately
positioned over the base of the external
oblique ridge of the mandible.
As no published method satisfies all
criteria for assessing facial swelling, we
decided to use the single sliding pointer
face-bow method that records one-
dimensional change only. This portable
appliance has been proven to be effec-
tive in prior investigations by others
including ALBUM et al.1 and HOLLAND12.
Facial swelling was recorded preo-
peratively and again 24 h postopera-
tively. Initial preoperative swelling
recordings provided a baseline reference
only. By subtracting this baseline value
from the recordings after 24 h, the actual
values for maximal facial swelling were
obtained. Published studies2,12,17 com-
monly used swelling recorded on the
first postoperative day as the measure
for maximal facial swelling, even though
maximal swelling may be attained vari-
Ice therapy and third molar surgery
ably between 24 and 48 h postopera-
tively. For this reason and for other
logistical reasons, swelling recorded
24 h postoperatively was used to deter-
mine maximal facial swelling.
The maximum mouth-opening ability
measured in millimetres was recorded
between the right upper and right lower
central incisors with the use of a Ver-
nier-calibrated sliding calliper. Mouth-
opening ability was recorded preopera-
tively, and 24 h postoperatively when
minimum mouth opening (maximum
trismus) was expected.
All patients were asked to judge the
efficacy of postoperative control of their
pain and discomfort over the first 24 h
following surgery on a scale of 1–5,
where 1 represented excellent control, 2
good, 3 moderate, 4 poor and 5 very
poor control of pain and discomfort.
Before discharge from the clinic, the
investigator ensured that all patients
knew how to complete the patient self-
assessment diary and when to take the
standardized medication and escape
medication. The patients returned the
completed form at the time of clinical
assessment 24 h postoperatively. All
patients were provided with home
instructions to ensure compliance.
Only side effects spontaneously per-
ceived by the patient were recorded in
the self-assessment diaries.
Data management and statistical ana-
lysis were performed by the Medical
Research Council using the Statistix V7
Table 1. Demographic distribution and surgical variables
Ice pack
Age (years)
Mean
SD
Sex
Male
Female
Weight (kg)
Mean
SD
Impaction type (N)
Mandibular 3rd molars
Bone impactions
Complete soft tissue
Partial soft tissue
Fully erupted
Maxillary 3rd molars
Bone impactions
Complete soft tissue
Partial soft tissue
Fully erupted
Missing
283
and Stata V6 Statistical Software
packages.
Results
The demographic distribution and base-
line values of the 60 patients in the trial
are presented in Table 1. It was con-
firmed that two groups did not differ
with respect to age, sex, weight, or
degree of surgical difficulty as deter-
mined by the type of impaction. Thirty
patients received bilateral facial ice
packs and 30 received no ice therapy.
The highest pain levels during the first
4 h postoperatively, were recorded 1 h
postoperatively for both treatment
groups (Fig. 1). Pain levels then gradu-
ally decreased for both trial groups dur-
ing the first 4 h postoperatively. No
statistical significant difference (P >
0.05) was observed for parameter of
pain during the first 4 h postoperatively
between the two treatment groups,
neither was a statistical significant dif-
ference (P > 0.05) found for pain
recordings on the evening following sur-
gery (EVE D0) nor the following morn-
ing (MRN D1) (Fig. 1).
On the day following surgery, mean
facial swelling of 6.0 and 4.6 mm were
recorded for the facial ice pack group,
on the left and right sides, respectively.
For the group that had received no ice
therapy the mean values were 6.4 and
5.4 mm on the left and right sides,
respectively (Fig. 2). Although mean
No ice therapy
21.5 21.4
3.6 3.5
8 13
22 17
65.7 69.9
8.5 12.9
29 30
22 13
9 17
0 0
16 17
26 10
7 9
6 17
5 1
284 van der Westhuijzen et al.
Fig. 1. Mean pain recordings—first 4 h postoperatively plus evening of surgery (EVE D0) and
morning following surgery (MRN D1).
Fig. 2. Maximal swelling in millimetres 24 h after surgery—left and right sides.
swelling was marginally lower for the
group that had received ice packs, this
was not statistically significant (P >
0.05).
The mean preoperative mouth opening
ability for the ice therapy group and the
group that received no ice therapy were
49.4 and 49.0 mm, respectively (Fig. 3).
By the morning of day 1 (24 h follow-
ing the surgical insult) the mean mouth
opening ability had decreased to
29.2 mm for the ice pack group and
27.4 mm for the group that received no
ice therapy (Fig. 3). This represented 59
and 55% of original preoperative mouth
opening ability, respectively. Even
though mean mouth opening ability was
marginally better after 24 h in the group
that had received ice-therapy, no statisti-
Table 3. Side-effects
Ice therapy No ice therapy
Nausea 5 3
Mild oozing 2 5
Total 7 8
and discomfort during the 24 h follow-
ing surgery (Table 2). Of the 26 patients
that rated postoperative control to have
been excellent, 18 had received ice
packs, while 8 had received no ice ther-
apy. Of the 29 patients that considered
the postoperative control to have been
good only, 19 had no ice therapy, while
10 received ice packs.
Compliance with the continuous use
the ice pack over the first 24 h period
following surgery varied between 2.8
and 21.3 h, with a mean of 11.3 h.
Three patients in the group that
received ice therapy resorted to escape
medication, 2 on the day of surgery and
1 the following day, while two in the
group that received no ice therapy used
their escape medication, 1 on the day of
surgery and 1 the following day. No sta-
tistical testing was possible due to the
small numbers.
The distribution of side-effects are
shown in Table 3. The small number of
side-effects reported were mild or mod-
erate and appeared related to the general
anaesthetic, surgery, or postoperative
medication. No side-effects that could
be attributed to the ice therapy were
reported. Statistical testing was limited
due to the small numbers, however, no
difference in overall frequency of side-
effects was found the between the two
treatment groups (Fisher exact
P ¼ 1.000).
No condition necessitated the withdra-
cally significant difference was found wal of any patients from the study.
between the two treatment groups either
pre- or postoperatively (P > 0.05).
Discussion
A statistically significant difference
(P ¼ 0.015) between the two treatment Benefits attributed to local cold applica-
groups was found, with respect to the tions include, prevention of edema by
patient’s subjective perception of the reducing the accumulation of fluid in
efficacy of control of postoperative pain body tissues, reduction in inflammation,
Table 2. Patient’s perception of postoperative control of symptoms
Frequency (N)
Ice therapy No ice therapy Total
Excellent 18 8 26
Good 10 19 29
Moderate 1 3 4
Total 29 30 59

Fig. 3. Interincisal opening—before surgery and 24 h after surgery.
slowing of metabolism, controlling
hemorrhage, retarding bacterial growth,
decrease in excitability of free nerve end-
ings and peripheral nerve fibers with
resultant increase in pain threshold,
decrease in enzymatic activity, temporary
decrease in spasticity, and a facilitation
of muscle contraction15. These therapeu-
tic effects are achieved by influencing
hemodynamic4,5,15,16,24, neuromuscu-
lar4,9,14,15,20,25 and metabolic processes4.
While the skin temperature changes
abruptly and markedly with the applica-
tion of cold, the deeper tissues are
cooled much less and more slowly and
depend on a number of variables3,15,
18,19,23
. test, using both alcohol and mercury
Prior to the study the skin and buccal
oral temperatures of a healthy young
female volunteer were recorded continu-
ously for 100 min following the applica-
tion and retention of the Tecnol1
bilateral ice packs around the face. The
cheek temperature was measured with a
thermometer positioned between the skin
and the pouches of the ice pack, and the
results reported in Fig. 4. It is interesting
to note that the abrupt decrease in skin
temperature to 16 8C, 50 min after
application of the ice pack, coincided
with the only recorded drop in buccal
oral temperature from 35.5 to 35.0 8C.
Buccal oral temperature was recorded
with an electronic temperature probe but
lacked sufficient clinical sensitivity
mainly because of the small decrease
observed. The 0.5 8C drop in buccal oral
temperature was maintained until record-
ings terminated after 100 min. Apart
from this observation that the only and
Ice therapy and third molar surgery
sustained drop in buccal oral tempera-
ture coincided with the most significant
drop in skin temperature, no other mean-
ingful conclusion could be drawn from
this. Skin temperature had bounced back
within 5 min, to settle at a steady
21 8C where it remained, while buccal
oral temperature remained 0.5 8C lower
until recordings were terminated after
100 min. Although the general rate of
decrease in skin temperature correlated
with that of the manufacturer’s data, we
did not find minimum skin temperatures
approaching 15 8C, except for a brief
period, 50–55 min after cold application
was commenced. In a further laboratory
thermometers, we confirmed that the
temperature between the ice-filled
pouches of a Tecnol1 bilateral ice pack,
Fig. 4. Cheek skin and buccal oral temperature recordings over 100 min with ice pack
positioned over the cheeks.
285
dropped, rapidly at first, from room tem-
perature (22 8C), to stabilize at 0 8C,
within 18 min of placing a thermometer
between the polyester outer layers of the
ice pack pouches, i.e. that part that
would normally be in contact with the
patient’s skin.
Most authors agree that pain follow-
ing third molar surgery reaches maxi-
mum intensity during the first 12 h after
surgery and that 97% of patients experi-
ence maximum pain levels on the day of
the operation10. Since the pain is of a
localized inflammatory kind, peripher-
ally acting analgesics such as the
NSAIDs have proven to be effective in
relieving postoperative pain11.
Trismus, limits mouth opening in an
attempt to prevent additional trauma or
pain after third molar surgery21. Recog-
nized regimens for treating trismus
would include ultrasonic therapy, phar-
macotherapeutics and cryotherapy.
Although our study found no statisti-
cally significant benefit by adding ice
therapy to the standardized analgesic/
anti-inflammatory compound for control
of postoperative pain, or swelling and
trismus over the first 24 h postopera-
tively, when swelling and trismus
approach maximum, the benefit of ice
therapy might have been more evident,
had patients in this study received
suboptimal doses of analgesics/anti-
inflammatories or no analgesics/anti-
inflammatories at all. The question
whether improvement in mouth opening
ability, after the initial 24 h, happens
faster or earlier where ice therapy had
been employed during the first 24 h
postoperatively, was not assessed in this
study.
Even though cryotherapy is a rela-
tively safe treatment modality, its use is
286 van der Westhuijzen et al.
considered to be contraindicated in
patients suffering from cold hypersensi-
tivities and intolerances, or over regen-
erating nerves, areas with impaired
circulation or peripheral vascular dis-
ease4. Cold therapy should be employed
with caution in patients with hyperten-
sion, poor sensation or mentation, and in
the very old and very young as they
may frequently have impaired thermal
regulation or a limited ability to commu-
nicate4. These contra-indications cer-
tainly apply to peripheral limbs, though
some of these may not be absolute con-
tra-indications in the oral and maxillofa-
cial region, with its superior collateral
blood supply.
Improper application of cryotherapy
may result in tissue death due to pro-
longed vasoconstriction, ischemia, and
capillary thrombosis4. Cold application
is generally limited to 15 min in distal
extremities, while longer treatment dura-
tions may be used for other areas24. No
adverse effects to cold were reported or
observed in our study, where ice therapy
was applied to the face and skin tem-
perature stabilized at 21 8C, despite
the fact that the ice packs were used
continually for up to 21 h.
Since, no statistical significant differ-
ence was found in reduction of post-
operative pain, swelling or trismus
between the two treatment groups, we
could not accept the hypotheses that ice
therapy administered by Tecnol1 bilat-
eral facial ice packs was superior to no
ice therapy in: (1) providing post-surgi-
cal analgesia, (2) reducing post-surgical
swelling, and (3) reducing trismus, dur-
ing the initial 24 h following third molar
surgery. However, with respect to
patients’ subjective perception of the
efficacy of control of postoperative pain
and discomfort over the first 24 h fol-
lowing surgery, Tecnol1 bilateral facial
ice packs proved to be superior to no
ice therapy.
The reasons why our study failed to
confirm the accepted view that cryother-
apy reduces the signs and symptoms of
acute inflammation are unclear. This
may be due to the fact that optimal
minimum skin temperature of 15 8C was
not achieved or maintained, that the ben-
efits of cold therapy were masked in the
presence of adequate analgesic/anti-
inflammatory control, or that ice therapy
applied without compression adversely
influenced our results. Recent prospec-
tive orthopaedic studies, that included
placebo groups as part of these studies,
have similarly shown no benefit from
cold therapy alone, and the question was
then raised as to whether some benefi-
cial effects attributed to cold therapy in
earlier studies, might have been due to
either the concomitant effects of com-
pression or a placebo effect in the treat-
ment group7,8,13,22. Further study in this
regard will be required to reach a con-
clusive answer.
Acknowledgments. The authors would like
to acknowledge Adcock Ingram Pharma-
ceuticals Ltd., South Africa, for donating
Myprodol capsules, the compound used as
analgesic and anti-inflammatory in this
study.
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Address:
Albert J. van der Westhuijzen
Department of Oral and Maxillofacial
Surgery
Dental Faculty
University of Stellenbosch
Private Bag X1
Tygerberg 7505
South Africa.
Tel: þ27 21 937 3089
Fax: þ27 21 931 2287
E-mail : AJVDW@sun.ac.za