Intravenous Ibuprofen Versus
diclofenac plus orphenadrine
in orthognathic surgery : A prospective,
randomized, double-blind, controlled clinical study
Sirirat Bongkotwilawan
intro
duction
NSAIDs
- Treatment of acute pain
- Lower side effect than opioid agents
- Ibuprofen intravenous (IV) form significantly reduced the use of both
morphine and postoperative pain in orthopedic surgery patients
- An 800-mg dose of IV ibuprofen reduction in narcotic needs for patients.
NSAIDs
Side effects
- Nausea
- GI bleeding
- Cardiovascular events
NSAIDs
Metamizole
- Non-opioid compound with potent analgesic, antipyretic and spasmolytic
effects
- Favorable gastrointestinal , cardiovascular and cerebrovascular profile
- Agranulocytosis, aplastic anemia, anaphylaxis and serious gastrointestinal
complications
nsaids
Diclofenac
- Relieve symptoms of arthritis
- Intravenous diclofenac 37.5 mg injection every 6 hours for acute moderate
to severe pain
- Adverse effect : risk of cardiovascular events and less risk for
gastrointestinal events
Material &
methods
Aim of this study
To assess pain scores in individuals receiving either ibuprofen or
diclofenac plus orphenadrine after orthognathic surgery
Inclusion criteria
- Age > 18 yrs
- Undergoing orthognathic surgery
Exclusion criteria
- Additional simultaneous operative nose or eye lid procedures
- Use of antidepressant drugs
- Chronic pain syndrome
- Baseline pain at admission
- Cognitive impairment
- Allergy, intolerance or contraindication to the investigational
medications
- Pregnant or breast feeding
Orthognathic surgery
Bimaxillary
Bilateral sagittal split osteotomy (BSSO)
Le fort I
Segmental osteotomy
Additional surgery ; chin osteotomy, SARPE
sample
- Stayed in the hospital for at least 3 days
- Patients with surgically assisted rapid palatal expansion (SARPE) were
discharged from the hospital after the latency period of 3 days
- Baseline measures : personal data, demographic characteristics and clinical data
GroupS
I-group D-group
Diclofenac 75 mg +
IV Ibuprofen 600 mg
Orphenadrine 30 mg
N = 56 Total N = 109 N = 53
Surgical procedures
● IV Ibuprofen 600 mg
or
● IV Diclofenac 75 mg
plus orphenadrine
● LA with 4% Articaine
or 4% Mepivacaine HCl
● Prednisolone IV 1
mg/kg As needed
● IV Metamizole 1 g
● IV Piritramide 3.75 mg
After surgery
days 1 2 3 4 5 Until
Discharge
2 times/day 2 times/day
1) Ibuprofen 600 mg 1) Ibuprofen 600 mg
or or
Diclofenac 75 mg + Diclofenac 50 mg +
Orphenadrine 30 mg Orphenadrine 30 mg
2) Metamizole 500 mg 2) Metamizole 500 mg
(3 times/day) (3 times/day)
Maximum daily dose : Ibuprofen 1200 mg, Diclofenac 150 mg
Rescue medication : Acetaminophen 1000 mg (3 times/day) ± Piritramide 7.5 mg (4 times/day)
Evaluation
days 0 1 2 3 4 Until
Discharge
Start record
at 4 h after 24 h NRS score ≤ 1 = Without pain / close to no pain
surgery
Pain score by Numeric
01. rating scale (NRS) Report only 1 score per POD
Record score every 6-8 h ,
3 times/day
Evaluation
Major adverse events from drugs
Total Opioid and
02. acetaminophen use Major post-operative complications
BMI, body weight, demographic data
Average day of hospital stay
Results
Demographic data
Number of patients 109
(I-group : 56, D-group : 53)
Sex Female 65 (59.63%)
Male 44 (40.36%)
Mean age Female 28 years
Male 28.4 years
(p=0.759)
Co-morbidity Smoking 11 (10.09%)
Anemia 2 (1.83%)
DM 2 (1.83%)
HT 2 (1.83%)
Thrombocytosis 2 (1.83%)
Bronchial asthma 2 (1.83%)
(p=0.987)
Orthognathic surgical subgroup analysis
Primary outcome : pain score
1.23
I-group 2.39 3.16 2.36 1.23
Mean of NRS
D-group 2.58 3.06 2.45 1.89
24h nrs score ≤ 1
No significant differences (p=0.549) between groups
I-group 7 patients (12.50%)
D-group 9 patients (16.98%)
Secondary outcome
Study variables NRS values
• Age
• Gender
• Length of stay
• Weight
• Length of operating times
BUT
Higher BMI Higher NRS values
At POD 2,3 for I-group & D-group
Secondary outcome
• Length of stay
I-group : 6.16 days ± 0.87 (range 5-8 days)
D-group : 6.21 days ± 1.12 (range 4-9 days) ; (p = 0.807)
• Operating time
Bimaxillary : 123.50 min Longest
Le fort I : 90.40 min
BSSO : 68.44 min
Segmental osteotomy : 18 min Shortest
Secondary outcome
• Breakthrough pain
Acetaminophen use
I-group : n = 78
D-group : n = 46 ; (p = 0.006)
Piritramide use
I-group : n = 31
D-group : n = 41 ; (p = 0.779)
Secondary outcome
• Chin osteotomies
Did not differ between groups
(n = 16 , 14.67%) ; (p = 0.654)
• Major postoperative complications
No
Discussion
Valuable analgesics in the
appropriate patients
Diclofenac and Ibuprofen
Higher rates of cardiovascular
side effects
Alternative tx
Acetaminophen or metamizole (mild-moderate pain)
Opioid
Fatal agranulocytosis and
Metamizole hepatotoxicity
In the present study, the authors found no adverse
events from metamizole
From review and position paper,
Diclofenac 25 patients encountered
cardiovascular events
In the present study, patient who received diclofenac plus
Orphenadrine had no serious adverse events
Assumption : Young age patients and less prone to cardiovascular
problems
Significant pain reduction in the bimaxillary subgroup treated with ibuprofen
Invasive Long operation time
Minor surgical complication : swelling, impaired mouth opening
Facial edema is not associated with pain severity
But
Higher BMI had the greatest amount of swelling
A placebo group was not included in the study
Ethical concerns about administering placebo
in patients with acute severe pain
Conclusion
- Intravenous ibuprofen is more suitable for reducing pain in
bimaxillary cases and high BMI patients than diclofenac plus
orphenadrine
critique
- Additional analgesic drug use
-Interval of analgesic drug
- NRS record timing
- Individual pain threshold were difference
- Several surgical procedure
Thank
you
