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Jim L Young - One of the best experts on this subject based on the ideXlab platform.
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single dose pharmacokinetics of 2 or 3 tablets of biphasic immediate release extended release Hydrocodone Bitartrate acetaminophen mnk 155 under fed and fasted conditions two randomized open label trials
BMC Clinical Pharmacology, 2015Co-Authors: Krishna Devarakonda, Kenneth Kostenbader, Michael J Giuliani, Jim L YoungAbstract:Biphasic immediate-release (IR)/extended-release (ER) Hydrocodone Bitartrate (HB)/acetaminophen (APAP) 7.5/325-mg tablets are formulated with gastroretentive ER drug delivery technology that has been associated with clinically meaningful food effects in other approved products. Two phase 1 studies evaluated potential effects of food on single-dose pharmacokinetics of IR/ER HB/APAP tablets. These were single-center, open-label, randomized, single-dose, 3-period crossover studies in healthy volunteers (aged 18–55 years). IR/ER HB/APAP was administered as a single 2-tablet dose (study 1) or 3-tablet dose (study 2) under fed (high- and low-fat) and fasted conditions. Area under the plasma concentration-time curve from 0 h to time t (AUC0–t) and from time 0 extrapolated to infinity (AUC0–inf) and maximum observed plasma concentration (Cmax) of Hydrocodone and APAP under fed versus fasted conditions were compared using analysis of variance. A 90 % confidence interval of the geometric least squares mean ratio fully contained within 80 to 125 % indicated no treatment difference. Safety and tolerability were assessed. Forty of 48 participants in study 1 and 21 of 30 in study 2 completed all treatments. In both studies, under fed (high- or low-fat meal) versus fasted conditions, 90 % CIs for AUC0–t and AUC0–inf for both Hydrocodone and APAP were entirely contained within the bioequivalent range (80–125 %), indicating that high- and low-fat meals did not affect the extent of exposure. In both studies, a high-fat meal did not affect the Cmax for Hydrocodone. Hydrocodone Cmax was not affected by a low-fat meal in study 1 but increased by approximately 19 % in study 2. A high-fat meal decreased APAP Cmax by approximately 20 % (study 1) and 13 % (study 2); a low-fat meal decreased APAP Cmax by 22 % (study 1) and 21 % (study 2). Approximately 50 % of participants in both studies reported ≥1 treatment-emergent adverse event (TEAE), with no notable difference based on food intake. There were no serious or severe AEs. The most common TEAEs were nausea, vomiting, and dizziness. Pharmacokinetic and safety findings were similar regardless of food intake. TEAEs were consistent with those reported with low-dose combination opioids. IR/ER HB/APAP can be administered without regard to food. ClinicalTrials.gov NCT02561650 and NCT02561741 .
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single and multiple dose pharmacokinetics of biphasic immediate release extended release Hydrocodone Bitartrate acetaminophen mnk 155 compared with immediate release Hydrocodone Bitartrate ibuprofen and immediate release tramadol hcl acetaminophen
Journal of Pain Research, 2015Co-Authors: Krishna Devarakonda, Kenneth Kostenbader, Michael J Giuliani, Jim L YoungAbstract:Objective To characterize the single-dose and steady-state pharmacokinetics (PK) of biphasic immediate-release/extended-release Hydrocodone Bitartrate/acetaminophen (IR/ER HB/APAP), IR HB/ibuprofen, and IR tramadol HCl/APAP.
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comparison of single dose and multiple dose pharmacokinetics between two formulations of Hydrocodone Bitartrate acetaminophen immediate release versus biphasic immediate release extended release
Journal of Pain Research, 2015Co-Authors: Krishna Devarakonda, Kenneth Kostenbader, Michael J Giuliani, Jim L YoungAbstract:Objective This study aimed to compare the single-dose and steady-state pharmacokinetics (PK) of biphasic immediate-release (IR)/extended-release (ER) Hydrocodone Bitartrate (HB)/acetaminophen (APAP) and IR HB/APAP.
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tolerability of biphasic release Hydrocodone Bitartrate acetaminophen tablets mnk 155 a phase iii multicenter open label study in patients with osteoarthritis or chronic low back pain
Clinical Therapeutics, 2015Co-Authors: Yanping Zheng, Kenneth Kostenbader, Michael J Giuliani, Thomas Barrett, Yin Chen, Elizabeth Hisaw, Jim L YoungAbstract:Abstract Purpose This study aimed to assess the tolerability of the extended use (≤35 days) of MNK-155, a biphasic (immediate-release/extended-release) Hydrocodone Bitartrate/N-acetyl-p-aminophenol (acetaminophen) (IR/ER HB/APAP) 7.5/325-mg fixed-dose combination analgesic agent, in patients with chronic noncancer pain (CNCP) caused by osteoarthritis or chronic low back pain. IR/ER HB/APAP tablets deliver 25% of the HB dose and 50% of the APAP dose by IR and the remainder by ER over a 12-hour dosing interval. Although IR/ER HB/APAP is being developed for the management of moderate to severe acute pain, this model of CNCP was used for assessing tolerability over a term longer than would be possible in a model of acute pain. Methods This Phase III, multicenter, open-label study enrolled patients with moderate to severe OA (knee or hip) pain despite the use of nonopioid or opioid analgesic agents, or with moderate to severe CLBP present for several hours per day for ≥3 months. Patients received a 3-tablet initial dose of IR/ER HB/APAP (total dose, 22.5/975 mg) on day 1, followed by 2 tablets of IR/ER HB/APAP (total dose, 15/650 mg) q12h for up to 35 days. Tolerability, the primary end point, was assessed using time to treatment discontinuation, the prevalence of treatment-emergent adverse events (TEAEs), vital sign measurements, pulse oximetry, clinical laboratory tests, and compliance. Secondary outcomes included the modified Brief Pain Inventory–Short Form, the Western Ontario and McMaster Universities Arthritis Index, and The Roland-Morris Low Back Pain and Disability Questionnaire. Findings Of the 153 patients enrolled (95 women [62.1%]; mean age, 53.9 [14.5] years; OA, n = 73; CLBP, n = 80), 37 (24.2%) discontinued the study early (mean time to discontinuation, 21.3 days). Thirteen patients (8.5%) discontinued because of TEAEs. A total of 88 patients (57.5%) reported ≥1 TEAE, 65 (42.5%) of whom experienced AEs considered by the investigator as treatment related. The most frequent TEAEs were nausea (16.3%), somnolence (14.4%), and constipation (11.1%). Eight severe TEAEs were experienced by 6 (3.9%) patients and included single occurrences of nausea, fatigue, nasopharyngitis, elevated liver enzymes, headache, nightmare, and ejaculation delay. No serious treatment-related AEs were reported. Clinically significant changes in laboratory values were reported in 13 patients, 6 of whom had abnormal liver function test results that did not meet Hy’s law criteria for acute liver failure. Most laboratory abnormalities were mild and transient. Measures of pain intensity, function, and quality of life improved from baseline but in an open-label study these changes cannot be attributed to treatment. Implications The safety profile of IR/ER HB/APAP during extended use was consistent with those of other low-dose opioid/APAP combination products. IR/ER HB/APAP is intended for acute pain; its efficacy for relief of CNCP would require further evaluation in an active- or placebo-controlled study. ClinicalTrials.gov Identifier: NCT01722864 .
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randomized double blind placebo controlled study of the efficacy and safety of biphasic immediate release extended release Hydrocodone Bitartrate acetaminophen tablets for acute postoperative pain
The Physician and Sportsmedicine, 2015Co-Authors: Neil Singla, Kenneth Kostenbader, Michael J Giuliani, Yanping Zheng, Thomas Barrett, Rachel Margulis, Yin Chen, Jim L YoungAbstract:AbstractBackground. A fixed-dose combination biphasic immediate-release (IR)/extended-release (ER) Hydrocodone Bitartrate (HB)/acetaminophen (APAP) tablet is being developed for the management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate. Methods. This Phase III, randomized, double-blind, placebo-controlled, parallel-group study evaluated the analgesic efficacy and safety of IR/ER HB/APAP (n = 201) versus placebo (n = 202) over a period of 48 hours in patients with acute moderate to severe pain following unilateral bunionectomy. Patients received three tablets of placebo or IR/ER HB/APAP as an initial dose (hour 0) followed by two tablets every 12 hours for a total daily dose of 37.5/1625 mg HB/APAP on day 1 and 30/1300 mg HB/APAP thereafter. The primary efficacy outcome was the summed pain intensity difference (SPID) over the first 48 hours (SPID48) after the first dose. Results. SPID48 was significantly greater with IR/ER HB/APAP vers...
Harry Wasvary - One of the best experts on this subject based on the ideXlab platform.
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a randomized prospective double blind placebo controlled trial of the effect of a calcium channel blocker ointment on pain after hemorrhoidectomy
Diseases of The Colon & Rectum, 2005Co-Authors: Ralph Silverman, Philip Bendick, Harry WasvaryAbstract:Spasm of the internal sphincter plays a role in hemorrhoidal disease and may be a source of anal pain after hemorrhoid surgery. We have evaluated the effects of topical diltiazem, a calcium channel blocker, in reducing pain after hemorrhoidectomy. After hemorrhoidectomy, 18 patients were randomly assigned to receive 2 percent diltiazem ointment (n = 9) or a placebo ointment (n = 9). Ointments were applied to the perianal region three times daily for seven days. Patients were prescribed Hydrocodone Bitartrate (Vicodin ®) to take as needed. The type and number of prescribed or nonprescribed medications taken during the postoperative period were recorded. Patients maintained a log to measure postoperative pain daily and perceived benefit of the ointment, using a Visual Analog Scale ranging from 0 to 10. Any postoperative morbidity noted during the follow-up period was recorded. Patients using the diltiazem ointment had significantly less pain and greater benefit than those in the placebo group throughout the first postoperative week. Postoperative pain scores in the placebo group averaged 8.8 ± 1.2 early and diminished to 5.2 ± 1.7 at the end of one week, compared to the diltiazem group of 5.2 ± 2.4 early and 2.3 ± 1.2 at the end of one week (P < 0.001, both time periods). Perceived benefit in the placebo group averaged 2.7 ± 1.2 vs. 5.6 ± 1.4 in the diltiazem group (P < 0.001). Total and daily narcotic use was higher in the placebo group, but this was not statistically significant (P = 0.13). No differences in the frequency of use of nonsteroidal anti-inflammatory drugs and acetaminophen were seen between the two groups, and there were no differences in morbidity between the two groups. Perianal application of 2 percent diltiazem ointment after hemorrhoidectomy significantly reduces postoperative pain and is perceived as beneficial, with no increase in associated morbidity. Patients using a placebo ointment tend to take more prescription narcotics for pain relief postoperatively, with a similar usage of nonsteroidal anti-inflammatory drugs and acetaminophen, although differences were not significant.
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randomized prospective double blind placebo controlled trial of effect of nitroglycerin ointment on pain after hemorrhoidectomy
Diseases of The Colon & Rectum, 2001Co-Authors: Harry Wasvary, Jon M Hain, Michele Mosedvogel, Philip Bendick, Donald Barkel, Steven KleinAbstract:PURPOSE: Fissure-in-ano is characterized by pain, bleeding, and internal anal sphincter hypertonicity. Spasm of the internal sphincter also plays a role in hemorrhoidal disease and may be a source of anal pain after hemorrhoid surgery. Inducing sphincter relaxation with a nitroglycerin ointment has shown promise in healing anal fissures and relieving symptoms of pain. Our study attempts to test the hypothesis that topical nitroglycerin applied to the perianal region is beneficial in reducing pain after hemorrhoidectomy. METHODS: After hemorrhoidectomy 39 patients were randomly assigned to receive 0.2 percent nitroglycerin ointment (n=19) or placebo (n=20). Ointments were applied to the perianal region three times daily for seven days. Patients were prescribed Hydrocodone Bitartrate to take as needed. Visual analog scales were used to measure postoperative pain intensity and ointment benefits. Patients completed questionnaires to record medication morbidity and number of prescribed or nonprescribed medications taken. RESULTS: Patients using nitroglycerin had less pain and greater benefit from ointment than those did in the placebo group, but differences were not significant. Narcotic use was higher in the placebo group when considered on a daily basis, but was statistically significant on the second postoperative day only (P<0.05). Morbidity from ointment application was significantly higher in the nitroglycerin group (P<0.002) and included a headache in 8 of 19 patients. Nonsteroidal anti-inflammatory drugs and acetaminophen were not prescribed, but were taken more frequently in nitroglycerin patients (P<0.0003). CONCLUSION: Perianal application of 0.2 percent nitroglycerin ointment after hemorrhoidectomy significantly reduced narcotic requirements on the second postoperative day. Headaches and a subsequent need for nonnarcotic medications may limit benefits of nitroglycerin.
Kenneth Kostenbader - One of the best experts on this subject based on the ideXlab platform.
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single dose pharmacokinetics of 2 or 3 tablets of biphasic immediate release extended release Hydrocodone Bitartrate acetaminophen mnk 155 under fed and fasted conditions two randomized open label trials
BMC Clinical Pharmacology, 2015Co-Authors: Krishna Devarakonda, Kenneth Kostenbader, Michael J Giuliani, Jim L YoungAbstract:Biphasic immediate-release (IR)/extended-release (ER) Hydrocodone Bitartrate (HB)/acetaminophen (APAP) 7.5/325-mg tablets are formulated with gastroretentive ER drug delivery technology that has been associated with clinically meaningful food effects in other approved products. Two phase 1 studies evaluated potential effects of food on single-dose pharmacokinetics of IR/ER HB/APAP tablets. These were single-center, open-label, randomized, single-dose, 3-period crossover studies in healthy volunteers (aged 18–55 years). IR/ER HB/APAP was administered as a single 2-tablet dose (study 1) or 3-tablet dose (study 2) under fed (high- and low-fat) and fasted conditions. Area under the plasma concentration-time curve from 0 h to time t (AUC0–t) and from time 0 extrapolated to infinity (AUC0–inf) and maximum observed plasma concentration (Cmax) of Hydrocodone and APAP under fed versus fasted conditions were compared using analysis of variance. A 90 % confidence interval of the geometric least squares mean ratio fully contained within 80 to 125 % indicated no treatment difference. Safety and tolerability were assessed. Forty of 48 participants in study 1 and 21 of 30 in study 2 completed all treatments. In both studies, under fed (high- or low-fat meal) versus fasted conditions, 90 % CIs for AUC0–t and AUC0–inf for both Hydrocodone and APAP were entirely contained within the bioequivalent range (80–125 %), indicating that high- and low-fat meals did not affect the extent of exposure. In both studies, a high-fat meal did not affect the Cmax for Hydrocodone. Hydrocodone Cmax was not affected by a low-fat meal in study 1 but increased by approximately 19 % in study 2. A high-fat meal decreased APAP Cmax by approximately 20 % (study 1) and 13 % (study 2); a low-fat meal decreased APAP Cmax by 22 % (study 1) and 21 % (study 2). Approximately 50 % of participants in both studies reported ≥1 treatment-emergent adverse event (TEAE), with no notable difference based on food intake. There were no serious or severe AEs. The most common TEAEs were nausea, vomiting, and dizziness. Pharmacokinetic and safety findings were similar regardless of food intake. TEAEs were consistent with those reported with low-dose combination opioids. IR/ER HB/APAP can be administered without regard to food. ClinicalTrials.gov NCT02561650 and NCT02561741 .
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single and multiple dose pharmacokinetics of biphasic immediate release extended release Hydrocodone Bitartrate acetaminophen mnk 155 compared with immediate release Hydrocodone Bitartrate ibuprofen and immediate release tramadol hcl acetaminophen
Journal of Pain Research, 2015Co-Authors: Krishna Devarakonda, Kenneth Kostenbader, Michael J Giuliani, Jim L YoungAbstract:Objective To characterize the single-dose and steady-state pharmacokinetics (PK) of biphasic immediate-release/extended-release Hydrocodone Bitartrate/acetaminophen (IR/ER HB/APAP), IR HB/ibuprofen, and IR tramadol HCl/APAP.
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comparison of single dose and multiple dose pharmacokinetics between two formulations of Hydrocodone Bitartrate acetaminophen immediate release versus biphasic immediate release extended release
Journal of Pain Research, 2015Co-Authors: Krishna Devarakonda, Kenneth Kostenbader, Michael J Giuliani, Jim L YoungAbstract:Objective This study aimed to compare the single-dose and steady-state pharmacokinetics (PK) of biphasic immediate-release (IR)/extended-release (ER) Hydrocodone Bitartrate (HB)/acetaminophen (APAP) and IR HB/APAP.
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tolerability of biphasic release Hydrocodone Bitartrate acetaminophen tablets mnk 155 a phase iii multicenter open label study in patients with osteoarthritis or chronic low back pain
Clinical Therapeutics, 2015Co-Authors: Yanping Zheng, Kenneth Kostenbader, Michael J Giuliani, Thomas Barrett, Yin Chen, Elizabeth Hisaw, Jim L YoungAbstract:Abstract Purpose This study aimed to assess the tolerability of the extended use (≤35 days) of MNK-155, a biphasic (immediate-release/extended-release) Hydrocodone Bitartrate/N-acetyl-p-aminophenol (acetaminophen) (IR/ER HB/APAP) 7.5/325-mg fixed-dose combination analgesic agent, in patients with chronic noncancer pain (CNCP) caused by osteoarthritis or chronic low back pain. IR/ER HB/APAP tablets deliver 25% of the HB dose and 50% of the APAP dose by IR and the remainder by ER over a 12-hour dosing interval. Although IR/ER HB/APAP is being developed for the management of moderate to severe acute pain, this model of CNCP was used for assessing tolerability over a term longer than would be possible in a model of acute pain. Methods This Phase III, multicenter, open-label study enrolled patients with moderate to severe OA (knee or hip) pain despite the use of nonopioid or opioid analgesic agents, or with moderate to severe CLBP present for several hours per day for ≥3 months. Patients received a 3-tablet initial dose of IR/ER HB/APAP (total dose, 22.5/975 mg) on day 1, followed by 2 tablets of IR/ER HB/APAP (total dose, 15/650 mg) q12h for up to 35 days. Tolerability, the primary end point, was assessed using time to treatment discontinuation, the prevalence of treatment-emergent adverse events (TEAEs), vital sign measurements, pulse oximetry, clinical laboratory tests, and compliance. Secondary outcomes included the modified Brief Pain Inventory–Short Form, the Western Ontario and McMaster Universities Arthritis Index, and The Roland-Morris Low Back Pain and Disability Questionnaire. Findings Of the 153 patients enrolled (95 women [62.1%]; mean age, 53.9 [14.5] years; OA, n = 73; CLBP, n = 80), 37 (24.2%) discontinued the study early (mean time to discontinuation, 21.3 days). Thirteen patients (8.5%) discontinued because of TEAEs. A total of 88 patients (57.5%) reported ≥1 TEAE, 65 (42.5%) of whom experienced AEs considered by the investigator as treatment related. The most frequent TEAEs were nausea (16.3%), somnolence (14.4%), and constipation (11.1%). Eight severe TEAEs were experienced by 6 (3.9%) patients and included single occurrences of nausea, fatigue, nasopharyngitis, elevated liver enzymes, headache, nightmare, and ejaculation delay. No serious treatment-related AEs were reported. Clinically significant changes in laboratory values were reported in 13 patients, 6 of whom had abnormal liver function test results that did not meet Hy’s law criteria for acute liver failure. Most laboratory abnormalities were mild and transient. Measures of pain intensity, function, and quality of life improved from baseline but in an open-label study these changes cannot be attributed to treatment. Implications The safety profile of IR/ER HB/APAP during extended use was consistent with those of other low-dose opioid/APAP combination products. IR/ER HB/APAP is intended for acute pain; its efficacy for relief of CNCP would require further evaluation in an active- or placebo-controlled study. ClinicalTrials.gov Identifier: NCT01722864 .
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randomized double blind placebo controlled study of the efficacy and safety of biphasic immediate release extended release Hydrocodone Bitartrate acetaminophen tablets for acute postoperative pain
The Physician and Sportsmedicine, 2015Co-Authors: Neil Singla, Kenneth Kostenbader, Michael J Giuliani, Yanping Zheng, Thomas Barrett, Rachel Margulis, Yin Chen, Jim L YoungAbstract:AbstractBackground. A fixed-dose combination biphasic immediate-release (IR)/extended-release (ER) Hydrocodone Bitartrate (HB)/acetaminophen (APAP) tablet is being developed for the management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate. Methods. This Phase III, randomized, double-blind, placebo-controlled, parallel-group study evaluated the analgesic efficacy and safety of IR/ER HB/APAP (n = 201) versus placebo (n = 202) over a period of 48 hours in patients with acute moderate to severe pain following unilateral bunionectomy. Patients received three tablets of placebo or IR/ER HB/APAP as an initial dose (hour 0) followed by two tablets every 12 hours for a total daily dose of 37.5/1625 mg HB/APAP on day 1 and 30/1300 mg HB/APAP thereafter. The primary efficacy outcome was the summed pain intensity difference (SPID) over the first 48 hours (SPID48) after the first dose. Results. SPID48 was significantly greater with IR/ER HB/APAP vers...
Steven Klein - One of the best experts on this subject based on the ideXlab platform.
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randomized prospective double blind placebo controlled trial of effect of nitroglycerin ointment on pain after hemorrhoidectomy
Diseases of The Colon & Rectum, 2001Co-Authors: Harry Wasvary, Jon M Hain, Michele Mosedvogel, Philip Bendick, Donald Barkel, Steven KleinAbstract:PURPOSE: Fissure-in-ano is characterized by pain, bleeding, and internal anal sphincter hypertonicity. Spasm of the internal sphincter also plays a role in hemorrhoidal disease and may be a source of anal pain after hemorrhoid surgery. Inducing sphincter relaxation with a nitroglycerin ointment has shown promise in healing anal fissures and relieving symptoms of pain. Our study attempts to test the hypothesis that topical nitroglycerin applied to the perianal region is beneficial in reducing pain after hemorrhoidectomy. METHODS: After hemorrhoidectomy 39 patients were randomly assigned to receive 0.2 percent nitroglycerin ointment (n=19) or placebo (n=20). Ointments were applied to the perianal region three times daily for seven days. Patients were prescribed Hydrocodone Bitartrate to take as needed. Visual analog scales were used to measure postoperative pain intensity and ointment benefits. Patients completed questionnaires to record medication morbidity and number of prescribed or nonprescribed medications taken. RESULTS: Patients using nitroglycerin had less pain and greater benefit from ointment than those did in the placebo group, but differences were not significant. Narcotic use was higher in the placebo group when considered on a daily basis, but was statistically significant on the second postoperative day only (P<0.05). Morbidity from ointment application was significantly higher in the nitroglycerin group (P<0.002) and included a headache in 8 of 19 patients. Nonsteroidal anti-inflammatory drugs and acetaminophen were not prescribed, but were taken more frequently in nitroglycerin patients (P<0.0003). CONCLUSION: Perianal application of 0.2 percent nitroglycerin ointment after hemorrhoidectomy significantly reduced narcotic requirements on the second postoperative day. Headaches and a subsequent need for nonnarcotic medications may limit benefits of nitroglycerin.
Philip Bendick - One of the best experts on this subject based on the ideXlab platform.
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a randomized prospective double blind placebo controlled trial of the effect of a calcium channel blocker ointment on pain after hemorrhoidectomy
Diseases of The Colon & Rectum, 2005Co-Authors: Ralph Silverman, Philip Bendick, Harry WasvaryAbstract:Spasm of the internal sphincter plays a role in hemorrhoidal disease and may be a source of anal pain after hemorrhoid surgery. We have evaluated the effects of topical diltiazem, a calcium channel blocker, in reducing pain after hemorrhoidectomy. After hemorrhoidectomy, 18 patients were randomly assigned to receive 2 percent diltiazem ointment (n = 9) or a placebo ointment (n = 9). Ointments were applied to the perianal region three times daily for seven days. Patients were prescribed Hydrocodone Bitartrate (Vicodin ®) to take as needed. The type and number of prescribed or nonprescribed medications taken during the postoperative period were recorded. Patients maintained a log to measure postoperative pain daily and perceived benefit of the ointment, using a Visual Analog Scale ranging from 0 to 10. Any postoperative morbidity noted during the follow-up period was recorded. Patients using the diltiazem ointment had significantly less pain and greater benefit than those in the placebo group throughout the first postoperative week. Postoperative pain scores in the placebo group averaged 8.8 ± 1.2 early and diminished to 5.2 ± 1.7 at the end of one week, compared to the diltiazem group of 5.2 ± 2.4 early and 2.3 ± 1.2 at the end of one week (P < 0.001, both time periods). Perceived benefit in the placebo group averaged 2.7 ± 1.2 vs. 5.6 ± 1.4 in the diltiazem group (P < 0.001). Total and daily narcotic use was higher in the placebo group, but this was not statistically significant (P = 0.13). No differences in the frequency of use of nonsteroidal anti-inflammatory drugs and acetaminophen were seen between the two groups, and there were no differences in morbidity between the two groups. Perianal application of 2 percent diltiazem ointment after hemorrhoidectomy significantly reduces postoperative pain and is perceived as beneficial, with no increase in associated morbidity. Patients using a placebo ointment tend to take more prescription narcotics for pain relief postoperatively, with a similar usage of nonsteroidal anti-inflammatory drugs and acetaminophen, although differences were not significant.
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randomized prospective double blind placebo controlled trial of effect of nitroglycerin ointment on pain after hemorrhoidectomy
Diseases of The Colon & Rectum, 2001Co-Authors: Harry Wasvary, Jon M Hain, Michele Mosedvogel, Philip Bendick, Donald Barkel, Steven KleinAbstract:PURPOSE: Fissure-in-ano is characterized by pain, bleeding, and internal anal sphincter hypertonicity. Spasm of the internal sphincter also plays a role in hemorrhoidal disease and may be a source of anal pain after hemorrhoid surgery. Inducing sphincter relaxation with a nitroglycerin ointment has shown promise in healing anal fissures and relieving symptoms of pain. Our study attempts to test the hypothesis that topical nitroglycerin applied to the perianal region is beneficial in reducing pain after hemorrhoidectomy. METHODS: After hemorrhoidectomy 39 patients were randomly assigned to receive 0.2 percent nitroglycerin ointment (n=19) or placebo (n=20). Ointments were applied to the perianal region three times daily for seven days. Patients were prescribed Hydrocodone Bitartrate to take as needed. Visual analog scales were used to measure postoperative pain intensity and ointment benefits. Patients completed questionnaires to record medication morbidity and number of prescribed or nonprescribed medications taken. RESULTS: Patients using nitroglycerin had less pain and greater benefit from ointment than those did in the placebo group, but differences were not significant. Narcotic use was higher in the placebo group when considered on a daily basis, but was statistically significant on the second postoperative day only (P<0.05). Morbidity from ointment application was significantly higher in the nitroglycerin group (P<0.002) and included a headache in 8 of 19 patients. Nonsteroidal anti-inflammatory drugs and acetaminophen were not prescribed, but were taken more frequently in nitroglycerin patients (P<0.0003). CONCLUSION: Perianal application of 0.2 percent nitroglycerin ointment after hemorrhoidectomy significantly reduced narcotic requirements on the second postoperative day. Headaches and a subsequent need for nonnarcotic medications may limit benefits of nitroglycerin.