Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06146491 |
| Other study ID # |
IRC/2223/022 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
August 10, 2023 |
| Est. completion date |
January 15, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
B.P. Koirala Institute of Health Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is comparative interventional study, will be conducted in patient indicated for surgical
extraction of mandibular third molar at the Department of Oral and Maxillofacial surgery,
College of Dental Surgery, BPKIHS, Nepal. Verbal and written will be taken . Participants
meeting inclusion criteria will be included in the study and will be divided in to two
groups, group A (Oral combination of paracetamol-500mg and ibuprofen -400mg) and group B (
Transdermal diclofenac patch-200mg) using computer generated randamization. Extraction will
be carried out using standard protocol. Aformention drugs will given to participants
accordingly for management of post operative pain.Tramadol will be given to each patient as
rescue analgesics and allowed to have if pain score exceeds 7.post operative instruction will
be given carefully. Rescue phone number will be provided in case of emergency. Telephonic
interview will be performed at 12, 24 and 72 hours post operatively and pain score using
numeric rating scale will be recorded.Any adverse effects of drugs will be recorded. The data
collected will be entered in Microsoft excel sheet. It will then be transferred into SPSS
(Statistical Package for Social Sciences) for statistical analysis.
Description:
Introduction:unpleasant sensory and emotional experience associated with, or resembling that
associated with, actual or potential tissue damage" is the new definition of pain as per IASP
2020. Pain is one of the most commonly experienced symptoms in oral and maxillofacial surgery
and as such is a major concern to the surgeon. One of the most important aspects of the
practice of dentistry is the control or elimination of pain. Pain is one of the most common
post-operative complication following surgical removal of mandibular third molar extraction.
To ameliorate the pain we commonly prescribe NSAIDS like oral Paracetamol ,ibuprofen, oral
diclofenac sodium etc. Non steroidal anti inflammatory drugs work well to relieve mild to
moderate intense postoperative pain. Their mechanism of action depends on whether they
inhibit cyclooxygenase-1 (COX-1), cyclooxygenase-2 (COX-2), or both, which are responsible
for the synthesis of different prostaglandins found in pathological situations (COX-2 is more
expressed in inflammatory conditions). NSAIDS can be administered in a variety of routes,
including oral, par-enteral, inhalation as well as trans dermal. Through Oral route is the
most common for the drugs delivery. Oral route carries the risk of first pass metabolism and
loss of substantial quantities of the drug before it is absorbed systemically. Par-enteral
administration of drugs can be extremely painful and sudden increase in drug concentration in
the plasma could lead to certain adverse effects. Trans dermal patches offer several
advantages over the oral route such as bypassing first pass metabolism, slow controlled
absorption, constant plasma concentration which is maintained for a longer duration, no
patient dependence for drug doses, no gastric discomfort, and flexibility of terminating the
drug administration by simply removing the patch from the skin.
Rarionale of the study:The three characteristics of the pain that occurs after routine tooth
extraction:(1) The Pain is usually not severe and can be managed in most patients with
over-the-counter analgesics, (2) the peak pain experience occurs about 12 hours after the
extraction and diminishes rapidly after that, and (3) significant pain from extraction rarely
persists longer than 2 days after surgery. Non steroidal anti inflammatory drugs (ibuprofen,
paracetamol etc )has the ability to reduce both pain and inflammation as a result they are
the ideal analgesic agents for the control of pain in the events of surgical removal of
mandibular third molar. NASIDS drugs can be administered in a variety of routes, including
oral, par enteral, inhalation as well as trans dermal. Oral route is the most common for the
drugs delivery. Oral NSAID may causes nephrotoxicity and hepatotoxicity'.Oral route carries
the risk of first pass metabolism and loss of substantial quantities of the drug before it is
absorbed systemically. Par enteral administration of drugs can be extremely painful and
sudden increase in drug concentration in the plasma could lead to certain adverse effects.
Trans dermal patches offer several advantages over the oral route such as bypassing first
pass metabolism, slow controlled absorption, constant plasma concentration which is
maintained for a longer duration, no patient dependence for drug doses, no gastric
discomfort, and flexibility of terminating the drug administration by simply removing the
patch from the skin. Plasma concentration of a topically applied NSAID was found to reach
only a fractional level (less than 5%) of that achieved after oral administration.[8] A lower
plasma drug concentration limits the systemic side effects and has an auxiliary advantage of
improved action at the site of inflammation. Trans dermal delivery is associated with a
lesser incidence of GI adverse effects and is particularly useful in patients unable to
tolerate an oral route. However, no such reduction was documented with occurrences of heart
and renal failure, which have been connected to oral NSAID usage.This study attempts to
compare effectiveness of trans dermal diclofenac and oral paracetamol + ibuprofen in
postoperative pain management following surgical extraction of mandibular third molar.
Sampling Method: purposive sampling
Expected sample size: study will be carried in 108 people visiting in oral and maxillofacial
department, BPKIHS for surgical extraction of mandibular third molar.
Procedure: All consecutive participants who met the inclusion criteria will allocated to the
oral paracetamol-500mg and ibuprofen-400mg ( group A) or trans dermal diclofenac-200mg (
group B) by computer generated random number .The surgical procedure will performed by same
surgeon under same environmen using standard surgical protocol. Local anaesthesia will be
provided by technique of regional blockade of the inferior and lingual alveolar nerves, with
supplementary buccal nerve infiltration. A careful and slow injection of the solution will
conducted after negative aspiration, with 2% lidocaine and 1:200,000 epinephrine. The
incision will be given as per wards incision technique. Howarth's periosteal elevator will be
used to reflect a full thickness mucoperiosteal flap and will be retracted with Austins re
tractor. Buccal and distal bone removal will be done with a round bur on a straight hand
piece under constant irrigation with 0.9% sterile normal saline solution and guttering done a
little beyond bifurcation. After the tooth delivery socket will be inspected, irrigated and
flap sutured with a 3-0 (vicryl). One suture will place just distal to the lower second molar
and another on the distal aspect of the extraction socket. Duration of surgical procedure
will be recorded. The post extraction instruction will be given carefully. Following removal
of the impacted mandibular third molar, the oral group will given 500mg paracetamol and
400mgtablet thrice daily 30 minute while the trans dermal diclofenac group will be given
diclofenac patch 200mg immediately after surgery daily for three consecutive days. Diclofenac
trans dermal patch will be placed on right arm. Information on regimen and application of
oral and trans dermal diclofenac was obtained from previous study[3] Patients were instructed
to apply 0.12% chlorhexidine digluconate aqueous solution to control dental plaque from the
second day, every 12 hours for 7 days. All patients will be given amoxicillin trihydrate.
500mg 8 hourly or erythromycin250mg 6 hourly for those who were allergic to penicillin,
metronidazole 400mg 8 hourly, both for five days .pentaprazole 40 mg daily for 5 days will be
given. These drugs were commenced immediately after surgery. Tramadol tablets 50mg every 8
hours will be prescribed as rescue analgesic and patients will be instructed to take it only
if pain score greater than 7. consent will be taken from All subjects verbal and written
patients will be taken , participaints will instructed to present to the emergency department
in the event of delayed post extraction complications like uncontrolled bleeding and
unbearable pain. The patients will be evaluated by the same observer. Pain will be evaluated
using a Numeric Rating Scale (NRS) by telephonic interview. The assessment of pain will be
done at three time points: 12, 24 and 72 hours post-operatively. The number of paracetamol
tablets taken after surgery by the patients will be recorded after 3 days post -operatively.
Statistical methods proposed:
Descriptive Analysis:
Descriptive statistics, such as mean, standard deviation, median, and percentage will be
applied.
Inferential statistics:
Student's t test or Mann Whitney u test will be applied to compare the observation between
the two groups.
Likewise chi square test will be used to compare the proportions between two groups.
