This paper is only available as a PDF. To read, Please Download here.
Abstract
Objective
The objective of this study was to compare the effectiveness of combination hydrocodone
and ibuprofen with that of combination oxycodone and acetaminophen in the treatment
of moderate to severe postoperative obstetric or gynecologic pain.
Background
Hydrocodone 7.5 mg with ibuprofen 200 mg is the only approved fixed-dose combination
analgesic containing an opioid and ibuprofen.
Methods
This randomized, double-blind, parallel-group, single-dose, active-comparator, placebo-controlled
study compared the effects of a 2-tablet dose of hydrocodone 7.5 mg and ibuprofen
200 mg with those of a 2-tablet dose of oxycodone 5 mg and acetaminophen 325 mg and
placebo. Analgesia was assessed over 8 hours.
Results
Mean pain relief (PR) scores were similar for the hydrocodone with ibuprofen and oxycodone
with acetaminophen groups (n = 61 and 59, respectively) at 0.5, 1, 1.5, 2, 2.5, 3,
4, and 7 hours and significantly greater for the hydrocodone with ibuprofen group
at 5, 6, and 8 hours (P ≤ 0.05). Mean pain intensity difference (PID) scores were similar for hydrocodone
with ibuprofen and oxycodone with acetaminophen at 0.5, 1, 1.5, 2, 2.5, 3, and 4 hours
and significantly greater for hydrocodone with ibuprofen at 5, 6, 7, and 8 hours (P ≤ 0 05). Total PR scores were similar for hydrocodone with ibuprofen and oxycodone
with acetaminophen for the 0- to 3- and 0- to 4-hour intervals and significantly greater
for hydrocodone with ibuprofen for the 0- to 6- and 0- to 8-hour intervals (P < 0.05). The sum of the PID scores was similar for hydrocodone with ibuprofen and
oxycodone with acetaminophen for the 0- to 3-, 0- to 4-, 0- to 6-, and 0- to 8-hour
intervals. The median estimated time to onset of analgesia, mean peak PR score, median
time to remedication, and mean global assessment score were similar for hydrocodone
with ibuprofen and oxycodone with acetaminophen. Assay sensitivity was demonstrated
by the presence of statistically significant differences between both active treatments
and placebo (n = 60). The number of patients experiencing adverse events was similar
for each of the 3 groups (11 [18.0%] hydrocodone with ibuprofen; 7 [ 11.9%] oxycodone
with acetaminophen; and 6 [10.0%] placebo).
Conclusions
In this study, a 2-tablet dose of combination hydrocodone 7.5 mg and ibuprofen 200
mg was as effective as a 2-tablet dose of combination oxycodone 5 mg and acetaminophen
325 mg in the treatment of moderate to severe postoperative obstetric or gynecologic
pain. Both treatments were superior to placebo. The results of this study suggest
that the combination of hydrocodone 7.5 mg and ibuprofen 200 mg may offer prescribers
an additional option in combination pain therapy.
Key words
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Clinical TherapeuticsAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Nonsteroidal anti-inflammatory analgesics and their combinations with opioids.in: Aronoff GM Evaluation and Treatment of Chronic Pain. 3rd ed. Williams & Wilkins, Baltimore, Md1999: 455-473
- Combination analgesics.Am J Med. 1984; 77: 38-53
- 4th ed. Principles of Analgesic Use in the Treatment of Acute and Cancer Pain. American Pain Society, Glenview, Ill1999: 5
- Acute pain management: Operative or medical procedures and trauma.in: Clinical practice guideline. AHCPR Publication 92-0032. Agency for Health Care Policy and Research, Rockville, Md1992
- Management of cancer pain.in: Clinical practice guideline No. 9. AHCPR Publication 94-0592. Agency for Health Care Policy and Research, Rockville, Md1994
- Cancer pain relief.World Health Organization, Geneva1986
- Analgesic efficacy of a combination of hydrocodone with ibuprofen in postoperative pain Clin.Pharmacol Ther. 1999; 65: 66-76
- Analgesic efficacy of a hydrocodone with ibuprofen combination compared with ibuprofen alone for the treatment of acute postoperative pain.J Clin Pharmacol. 1997; 37: 908-915
- Data on file.in: VP-04 Mount Olive. Knoll Pharmaceutical Company, NJ1996
- Assessment of dose response of hydrocodone bitartrate with ibuprofen in acute postsurgical pain Clin.Pharmacol Ther. 1997; 61 (Abstract): 200
- Analgesic Efficacy of Hydrocodone and Its Combinations: A Review. Springhouse, Pa Smith Simon, 1988
- Cyclooxygenase-1 and cyclooxygenase-2 selectivity of widely used nonsteroidal anti-inflammatory drugs.Am J Med. 1998; 104: 413-421
- Multiple Comparison Procedures. John Wiley & Sons, New York1987: 3
- Choosing a pharmacotherapeutic approach: Nonopioid and adjuvant analgesics.in: Borsook D LeBel AA McPeek B Massachusetts General Handbook of Pain Management. Little Brown & Company, Boston, Mass1995: 76-104
- Evaluation of ketorolac, ibuprofen, acetaminophen, and an acetaminophencodeine combination in postoperative oral surgery pain.Pharmacotherapy. 1990; 10 (6 Pt 2): 94S-105S
- Multicenter clinical tnal of ibuprofen and acetaminophen in the treatment of postoperative dental pain.J Am Dent Assoc. 1990; 121: 257-263
- Five studies on lbuprofen for postsurgical dental pain.Am J Med. 1984; 77: 70-77
- Impact of non-narcotic oral analgesics on pain management.Am J Med. 1988; 84: 3-15
- Management of cancer pain: Adults.Am J Hosp Pharm. 1994; 51: 1643-1656
- When acetaminophen use becomes toxic.Treating acute accidental and intentional overdose.Postgrad Med. 1999; 105: 81-90
- Etiology and outcome for 295 patients with acute liver failure in the United States.Liver Transplant Surg. 1999; 5: 29-34
- Acetaminophen toxicity in an urban county hospital.N Engl J Med. 1997; 337: 1112-1117
- Acetaminophen (paracetamol) hepatotoxicity with regular intake of alcohol· Analysis of instances of therapeutic misadventure.Hepatology. 1995; 22: 767-773
- Acetaminophen hepatotoxicity, fasting, and ethanol.JAMA. 1995; 274 (Letter): 301
- Abnormal serum transaminases following therapeutic doses of acetaminophen in the absence of known risk factors.Dig Dis Sci. 1995; 40: 1951-1955
- Association of acetaminophen hepatotoxicity with fasting and ethanol use.JAMA. 1994; 272: 1845-1850
- Vicodin-induced fulminant hepatic failure.Anesthestology. 1993; 79: 857-860
- Individual nonsteroidal anti-lnflammatory drugs and other risk factors for upper gastrointestinal bleeding and perforation.Epidemiology. 1997; 8: 18-24
- Nonsteroidal antinflammatory drugs, ulcers and risk. A collaborative meta-analysis.in: Semin Arthritis Rheum.26. 1997: 16-20 (6 Suppl 1)
- NSAIDs· Time to re-evaluate gut toxicity.Lancet. 1994; 343 (Comment): 1051-1052
- Risks of bleeding peptic ulcer associated with individual non-steroidal anti-inflammatory drugs.Lancet. 1994; 343: 1075-1078
- Risk of upper gastrointestinal bleeding and perforation associated with individual non-steroidal anti-inflammatory drugs.Lancet. 1994; 343: 769-772
- Variability in risk of gastrointestinal complications with individual nonsteroidal anti-inflammatory drugs Results of a collaborative meta-analysis.Br Med J. 1996; 312: 1563-1566
- The safety profile of nonprescription ibuprofen in multiple-dose use. A meta-analysis.J Clin Pharmacol. 1999; 39: 520-532
- Bromfenac sodium, acetaminophen/oxycodone, lbuprofen, and placebo for relief of postoperative pain.Clin Ther. 1997; 19: 507-519
- Ketoprofen, acetaminophen plus oxycodone, and acetaminophen in the re-lief of postoperative pain.Clin Pharmacol Ther. 1993; 54: 546-555
Article info
Publication history
Accepted:
March 8,
2000
Footnotes
*Trademark Vicoprofen® (Knoll Pharmaceutical Company, Mount Olive, New Jersey).
Identification
Copyright
© 2000 Published by Elsevier Inc.
