| Author Year UI | Treatment of breakthrough pain or escape medication (applies to all arms) | Outcomes assessed (pain relief, QOL, etc) | Instruments used for the assessment of studied effects | ||||||||||
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| NSAIDs VS NSAID n=1 | |||||||||||||
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Pannuti 1999 99291253 | No other medication was given during the study | Pain Intensity, nausea, sedation, rescue analgesic dose. | Variables were assessed after single-dose administration (8 hr after administration) and at the end of a 7-day repeated dose administration period. Instruments used: VAS (0-10cm) and 5-point Verbal Rating Scale (VRS; 0=no pain; 1=mild; 2=moderate; 3=severe; 4=extreme pain). Three variables were assessed:
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| OPIOID VS OPIOID n=6 | |||||||||||||
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Moolenaar 2000 20407008 | Acetaminophen (500 mg) | Pain intensity, side-effects and rescue medication, plasma levels of M, M-6-G and M-3-G at 0, 1, 2, 4, 6 and 12 hr at day 5 and day 10 | VAS, 0-10cm assessed by patient every 2 hr, side-effects and rescue medication were recorded. | ||||||||||
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Heiskanen 2000 21075895 | The respective oral solution was administered as escape medication in a dose approximately 1/6 to 1/8 of the daily dose of CR oxycodone or CR morphine. | Plasma levels of drugs and metabolites at the last day of each period of dosing and before the start of the next period. Plasma levels were determined at 0 (before dosing), 1h, 3h and 5h after dosing. Pharmacodynamic assessments at the same days and prior to dosing and determinations of plasma levels were pain intensity | VASpi, 4-point verbal rating scale, subjective drug effect questionnaire and modified specific drug effect questionnaire. Phenotyping to determine CYP2D6 was also performed. | ||||||||||
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Hunt 1999 99414499 | Meperidine s.c. was used as a breakthrough pain medication using a dose of one/sixth of the 24-hour sc infusion dose and a conversion factor of morphine sulfate 10 mg sc meperidine 100 mg sc. Two or more doses of breakthrough medication in a 24-hour period resulted in a 30% increase in the sc infusion dose for the following day. Routine administration of nonopioid medication continued throughout the 6 days of the study period. | Pain intensity and pain relief, nausea, mental status, itching, hallucinations, myoclonus. | Patients were asked three questions to quantify their pain at the end of the morning and afternoon shifts. 1) VAS, 0-10 pain intensity now, 2) VAS, 0-10 pain intensity overall over the shift period, and 3) Has the pain been controlled for 50% of the shift (Y/N). Pain scores and nausea scores (0-10, 0 no nausea, 10 worst imaginable nausea) were recorded by nurses on a daily observation sheet. Mental status was assessed using the Saskatoon Delirium Checklist at the same times as pain intensity and nausea. A record of medication used during the study and the number of bowel movements were maintained for the 6 days of the study. Side-effects such as itching, myoclonus and hallucinations were asked about and recorded if present. Trail making and semantic fluency tests were used to assess cognitive function at the end of days 3 and 6. Overall preference for the first or the second opioid was recorded at the end of the sixth day. Venous blood samples for plasma drug concentrations were collected at the end of each 72-hour period. | ||||||||||
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Bruera 1999 99349918 | Patients were allowed to receive extra doses of immediate-release morphine as frequently as needed in the form of a tablet or a suppository, each such rescue dose being approximately 10% of the daily opioid dose. Patients who required more than three rescue doses had their MS-CRS dose increased and underwent a further 24-hr observation and dose stabilization period. | a) pain intensity, b) sedation, c) nausea, d) overall effectiveness by patient and investigator, e) treatment preference, f) type, severity and frequency of adverse events was recorded |
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Mercadante 1998 99032200 | The use of other drugs was allowed. Nonopioid analgesics were continued if not contraindicated. No other information is available on breakthrough pain medication. | a) performance status b) opioid starting dose (OSD) in milligrams at referral c) maximum dose of opioids (OMD) in milligrams d) days of opioid treatment e) adjuvant medication, which included nonopioid analgesics administered for at least 10 days and their doses f) symptoms associated with opioid therapy and or commonly present in patients with advanced cancer, such as nausea or vomiting, drowsiness, confusion or xerostomia g) pain intensity was measured using the patient's self report or a doctor's rated visual analogue scale h) pain syndromes were considered on the basis of clinical history, anatomic site of the primary tumor and known metastases, physiscal examination, and investigations when available. | The following indices were calculated:
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Parris 1998 99019888 | Patients who required supplemental analgesia were excluded. Patients needing titration of analgesic or supplemental medication were required to discontinue from the study. | Primary efficacy measures were: a) mean pain intensity by day (the average of the four categorical scale ratings for pain intensity for each study day) b) mean acceptability of therapy by day (the average of the two categorical scale ratings for acceptability of therapy for each study day). Other efficacy measures included mean pain intensity and mean acceptability of therapy by time of day, overall mean pain intensity and acceptability of therapy and discontinuation rates both overall and by reason. Safety was evaluated by adverse effects obtained by questioning and/or examining the patients. Discontinuation rates because of adverse effects were determined. | During the double-blind period patients rated: a) pain intensity in a diary four times daily: morning (overnight pain rating), midday (morning pain rating), evening (afternoon pain rating), and bedtime (evening pain rating). A four-point categorical (CAT) scale of 0=none, 1=slight, 2=moderate, and 3 = severe was used for these ratings. b) acceptability of therapy considering both pain intensity and side-effects for both day and night. Acceptability of therapy was rated on a five-point CAT scale of 1=very poor, 2=poor, 3=fair, 4=good,, and 5=ecxellent. | ||||||||||
| BREAKTHROUGH PAIN, n=1 | |||||||||||||
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Portenoy 1999 99165545 | Not applicable, because the study is on the treatment of breakthrough pain. | The primary outcome data comprised pain scores collected during the treatment of one or two episodes of breakthrough pain during both baseline days and the 2 days following successful titration of the OTFC dose. | Immediately before drug administration, patients recorded pain intensity using an 11-point numerical scale (0, no pain; 10, pain as bad as you can imagine). Measurements of pain intensity and pain relief were recorded at approximately 15, 30 and 60 min after starting treatment. Pain relief was assessed using a four-point categorical scale (0, "none"; 4, "complete"). A global impression of the drug's performance which used a rating from 0 (poor) through 4 (excellent), was recorded once daily. Adverse events were elicited by the study nurse at the time of each patient contact. Data on pain intensity, pain relief and global performance were averaged per patient and across patients for each phase of the study (baseline and titration phases). Pain intensity difference (PID) was calculated for three intervals (i.e. 0-15 min, 12-30 min and 30-60 min). | ||||||||||
| ADJUVANTS n=5 | |||||||||||||
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Dahm 2000 20462757 | During the IT treatment, the patients had ad libitum access to non-opioid analgesics/sedatives and to opioids administered by the oral and/or parenteral route until they obtained acceptable pain and anxiolytic relief. | a) daily doses of local ansthetics administered IT and of opioids administered by the oral/parenteral routes, expressed as mg parenteral morphine-Eq/day. b) self-reported pain intensity c) sleep pattern d) side-effect and complications (i.e. paresthesia, paresis, urinary retention, transient cerebral ischemic attacks, etc.) e) patients assessment of the trial periods. |
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Mercadante 2000 99032200 | Not stated | a) pain intensity b) assessment of nausea, vomiting, drowsiness, confusion, and dry mouth c) Mental state d) arterial pressure e) side effects All outcomes were recorded before drug administration (T0), and 30 min (T30), 60 min (T60), and 180 min (T180) after. |
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Lauretti 1999 99287592 | Patients were free to manipulate and increase their daily morphine consumption by self-administration only at the time the epidural study drug was added, in order to maintain VAS below 4/10. | Duration of effective analgesia, incidence of adverse effects, consumption of morphine. | Duration of effective analgesia was measured as time from the study drug administration to the first patient's VAS score >=4/10 recorded in days. | ||||||||||
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Lauretti 1999 99287592 | After the test drug was introduced all patients were free to manipulate their daily morphine consumption by adding more morphine to the 80- to 90- mg dose, to keep pain VAS less than 4. | Daily morphine consumption, pain intensity, adverse effects. All measurements were repeated on days 1, 5, 10, 15, 20, and 30 after the test drug was introduced. | VAS (0-10) for pain intensity. | ||||||||||
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Van Dongen 1999 99452099 | Not reported | Pain intensity, side effects. | Verbal rating scale, numerical rating scale, VAS; use of concomitant analgesics; quality of pain relief from general physician (frequency of assessment not reported); increase in IT morphine dose by linear regression analysis from day 10 to 30 | ||||||||||
From: Evidence Tables
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