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Pain outcomes of pediatric circumcision patients following administration of pre-operative ketorolac: A randomized clinical trial.

INTRODUCTION: Circumcision is a common surgical intervention, and pain is the most common complaint. Poorly managed pain can increase morbidity and reduce patient and parent satisfaction. Ketorolac, a non-steroidal anti-inflammatory drug (NSAID), provides analgesia and may be effective in reducing pain after circumcision in pediatric patients. STUDY OBJECTIVES: The primary objective was to determine the effect of pre-operative intravenous ketorolac versus normal saline placebo on parental perception of postoperative pain at 24 h. We also explored the effect of ketorolac on postoperative pain scores, incidence of bleeding, incidence of vomiting, and analgesic use. MATERIALS AND METHODS: A prospective, randomized, single-blinded trial was conducted at a single tertiary children's hospital. Patients aged 1-17 presenting for circumcision were included and randomized to either normal saline injectate or ketorolac (0.5 mg/kg, maximum 30 mg). Postoperative delirium and pain scores were recorded in the post-anesthetic care unit. Parents completed the parents' postoperative pain measure (PPPM) at 24 h. The CONSORT criteria and checklist were used to guide reporting of this randomized controlled trial. RESULTS: A total of 100 participants were included. 50 participants were in each group. Mean (SD) PPPM score 24 h after normal saline and ketorolac was 6.1 (3.4) and 5.5 (3.3), respectively for a mean difference of -0.55 points [95% CI: -1.9 to 0.83; p = 0.427]. The mean (95% CI) fixed effect size of ketorolac on post anesthetic care unit reported Face, Leg, Activity, Cry, Consolability score was -0.17 (-0.77 to 0.43, p = 0.585) points, while the mean (95% CI) effect size of ketorolac on numerical rating scale was -1.2 (-2.2 to -0.18, p = 0.026) points. DISCUSSION: Pre-operative intravenous ketorolac, compared to normal saline placebo, did not result in a difference in parental perception of postoperative pain at 24 h after circumcision surgery. As part of exploratory analyses, those receiving ketorolac had modestly lower mean immediate postoperative pain scores, likely not of clinical importance. Ketorolac has often been avoided due to concerns of increased bleeding risk, however it is important to consider that there is no substantial evidence to support this. This is the first study to our knowledge evaluating the effect of ketorolac in pediatric circumcision patients. While the PPPM score is a family centered outcome, it is an indirect measurement of pediatric pain. CONCLUSIONS: Pre-operative intravenous ketorolac was not associated with lower parental reported pain scores at 24 h compared to normal saline placebo after pediatric circumcision surgery. CLINICAL TRIAL REGISTRATION: NCT02973958.

Humans

Clinical pharmacokinetics of ketorolac tromethamine.

Ketorolac is a new chiral nonsteroidal anti-inflammatory drug (NSAID) which is marketed for analgesia as the racemate. The drug is administered as the water soluble tromethamine salt and is available in tablets or as an intramuscular injection. The absorption of ketorolac is rapid, Cmax being attained between 20 to 60 min. Its oral bioavailability is estimated to range from 80 to 100%. The drug is extensively bound (> 99%) to plasma proteins and has a volume of distribution (0.1 to 0.3 L/kg) comparable with those of other NSAIDs. Only small concentrations of ketorolac are detectable in umbilical vein blood after administration to women in labour. The elimination half-life is between 4 and 6h and is moderate in comparison with other NSAIDs. The area under the plasma concentration-time curve of ketorolac is proportional to the dose after intramuscular administration of therapeutic doses to young healthy volunteers. Ketorolac is extensively metabolised through glucuronidation and oxidation; little if any drug is eliminated unchanged. Most of the dose of ketorolac is recovered in the urine as conjugated drug. Although ketorolac is excreted into the breast milk, the amount of drug transferred comprises only a small fraction of the maternal exposure. Little stereoselectivity was present in the pharmacokinetics of ketorolac in a healthy volunteer receiving single intravenous or oral doses. The elderly exhibit reduced clearance of the drug. Renal insufficiency appears to cause an accumulation of ketorolac in plasma, although hepatic disease may not affect the pharmacokinetics.

Absorption

Comparison of intravenous ketorolac with morphine for postoperative pain in children.

Ninety-two children from 3 to 12 years of age were given intravenous morphine or ketorolac by titration, or ketorolac by bolus injection for moderate or severe postsurgical pain in a double-blind randomized parallel-group study. Pain scores were assessed every 5 minutes until pain relief was complete, and then every 15 minutes for 8 hours or until pain returned. Twenty-nine of 30 patients receiving morphine and 25 of 30 patients in each group receiving ketorolac achieved pain relief. The subjects in the morphine group required statistically fewer doses for analgesia than the subjects in the ketorolac groups. The sums of pain intensity differences calculated from the start of the study numerically favored morphine, but the sum of pain intensity differences from pain relief until 50% withdrew were significantly better in the ketorolac groups. Median durations of analgesia from initial drug administration were 170, 190, and 225 minutes in the morphine, ketorolac titration, and ketorolac bolus groups, respectively. The most common side effect was injection site pain. Analgesia after intravenous ketorolac developed more slowly but was sustained better than morphine.

Analgesics

Comparative effects of ketorolac, dezocine, and fentanyl as adjuvants during outpatient anesthesia.

The comparative effects of ketorolac, dezocine, and fentanyl were evaluated in 136 healthy female patients undergoing outpatient laparoscopic procedures according to a randomized, double-blind protocol. Patients received ketorolac (60 mg) or dezocine (6 mg) or fentanyl (100 micrograms, control group) before the start of the operation. A standardized general anesthetic technique consisting of midazolam (2 mg), fentanyl (50 micrograms), and propofol (2 mg/kg) for induction of anesthesia followed by propofol (120 micrograms.kg-1.min-1), vecuronium (1-2 mg), and 67% nitrous oxide in oxygen for maintenance of anesthesia, was used. In the postanesthesia care unit, 61% of patients in the fentanyl group received analgesic drugs for persistent pain, compared with 34% and 25% in the ketorolac and dezocine groups, respectively. Similarly, less postoperative fentanyl (mean +/- SD) was required in the ketorolac (22 +/- 33 micrograms) and dezocine (18 +/- 35 micrograms) groups, compared with the fentanyl (58 +/- 71 micrograms) group. However, 52% of the patients receiving dezocine required antinausea therapy in the postanesthesia care unit, compared with 20% and 18% in the fentanyl and ketorolac groups, respectively. Finally, recovery times were significantly shorter in the ketorolac (vs dezocine) group. Although both ketorolac and dezocine were effective alternatives to fentanyl when administered during outpatient laparoscopy, dezocine was associated with an increased incidence of postoperative nausea and a delayed discharge time compared with ketorolac.

Adjuvants, Anesthesia

A randomized, double-blind, comparative study of the efficacy of ketorolac tromethamine versus meperidine in the treatment of severe migraine.

STUDY OBJECTIVE: To evaluate the relative efficacy of ketorolac tromethamine and meperidine hydrochloride in the emergency department treatment of severe migraine. DESIGN: Prospective, randomized, double-blind trial. SETTING: University hospital ED. PARTICIPANTS: Patients presenting to the ED with an isolated diagnosis of common or classic migraine. INTERVENTIONS: Subjects were randomized to receive a single intramuscular injection of either 30 mg ketorolac or 75 mg meperidine. MEASUREMENTS AND MAIN RESULTS: Of the 31 patients completing the trial, 15 received ketorolac and 16 received meperidine. The demographic characteristics of both groups were comparable. At one hour, ketorolac was significantly less effective than meperidine in reducing headache pain (P = .02) and in improving clinical disability (P = .01). Ketorolac also was less effective at reducing nausea, photophobia, and the need for rescue medication (P less than .05). Sustained headache relief was experienced by 44% of the patients treated with meperidine at 12- to 24-hour follow-up, compared with 13% of the patients treated with ketorolac (P = NS). No significant side effects were observed for either group. CONCLUSION: IM ketorolac tromethamine is less effective than meperidine in the ED treatment of severe migraine.

Acute Disease

Inhibition of some human neutrophil functions by the cyclooxygenase inhibitor ketorolac tromethamine.

Ketorolac tromethamine, a new nonsteroidal anti-inflammatory agent of the pyrrolo-pyrrole group, was assayed for inhibitory effects on polymorphonuclear leukocytes (PMN) in a variety of systems. Ketorolac inhibited PMN superoxide anion generation, lysozyme release, myeloperoxidase release, adherence to plastic surfaces, and chemotaxis in response to N-formyl-methionyl-leucyl-phenylalanine (fMLP) in a dose-dependent manner. Ketorolac also inhibited phorbol myristate acetate-stimulated adherence of PMN to bovine pulmonary artery endothelial cells. The drug inhibited lysozyme and myeloperoxidase release by PMN in response to C5a but failed to inhibit C5a stimulation of PMN in any of the other assays. Levels of ketorolac required to inhibit PMN function in most systems were in the range of 0.2 to 1.0 mg/ml, but chemotaxis to fMLP was inhibited by concentrations of ketorolac as low as 1 microgram/ml. Ketorolac, currently the only nonsteroidal anti-inflammatory drug available in a parenteral form may have therapeutic usefulness in a variety of conditions thought to be mediated in part by PMN, including sepsis.

Anti-Inflammatory Agents, Non-Steroidal

Ketorolac trometamol for postoperative analgesia after orthopaedic surgery.

We have compared the postoperative morphine requirements and analgesic efficacy of four doses of i.m. ketorolac 30 mg administered 6-hourly with placebo in a double-blind study of patients undergoing major or minor orthopaedic surgery. During the 24-h postoperative study period which began at the end of surgery, patients were prescribed i.m. morphine 10 mg as required 2-hourly and assessments were made of pain at 4 and 24 h. After major surgery, the median morphine consumption over 24 h was 10 mg in patients who received ketorolac, compared with 30 mg in those who received placebo (P = 0.008). Visual analogue pain scores and verbal pain assessments were better than placebo at 4 h (P = 0.028 and P = 0.008, respectively), but were not statistically different between the groups at 24 h. Overall assessment of pain was similar in both groups who had undergone major surgery. In the minor surgery groups, median morphine consumption was 0 mg in patients who received ketorolac, compared with 10 mg in those given placebo (ns). Visual analogue pain scores at 24 h after surgery were significantly less in patients who had received ketorolac compared with placebo (P = 0.046) and the overall assessment of pain relief was better in the ketorolac group (P = 0.0007). Mandatory administration of ketorolac appeared to be of benefit in both major and minor orthopaedic surgery, although the principal effects were reduction in requirement for supplementary morphine for major surgery and better overall analgesia for minor surgery.

Adolescent

Acute renal failure in an elderly woman following intramuscular ketorolac administration.

OBJECTIVE: To report a case of ketorolac tromethamine-induced acute renal failure and to discuss the risk factors that make patients more susceptible to the renal effects of nonsteroidal antiinflammatory drugs (NSAIDs). DATA SOURCES: Case reports and review articles identified by MEDLINE. Indexing terms included ketorolac, renal failure, and NSAIDs. DATA EXTRACTION: Data were abstracted from pertinent published English-language sources and were reviewed by all authors. DATA SYNTHESIS: Ketorolac is an intramuscularly administered NSAID with many of the same adverse effects associated with other oral NSAIDs. Although reversible depression of renal function has been associated with several NSAIDs, to date there have been no published reports of acute renal failure secondary to ketorolac administration. A 71-year-old woman received three doses of ketorolac to control the pain associated with pelvic and T11-T12 compression fractures. Over the next two days, the patient developed signs and symptoms of acute renal failure, including significant increases in blood urea nitrogen, serum creatinine, and peripheral edema. These signs and symptoms resolved over the next three to four days. Certain risk factors, several of which were present in this woman, make individual patients more susceptible to the renal affects of NSAIDs. These risk factors include advanced age, cirrhosis, volume depletion, congestive heart failure, gastrointestinal bleeding, and preexisting mild renal dysfunction. CONCLUSIONS: Caution should be taken when initiating ketorolac or any NSAID therapy with specific attention to risk factors that predispose a patient to renal dysfunction.

Aged

Ketorolac: a new parenteral nonsteroidal anti-inflammatory drug for postoperative pain management.

Providing adequate pain control with minimal side effects in inpatient and ambulatory settings is a continuous challenge to the PACU nurse. Ketorolac tromethamine (Toradol, Syntex, Palo Alto, CA) is a new parenteral nonsteroidal anti-inflammatory drug (NSAID) approved for use in the United States. Ketorolac is useful in the management of short term, moderate to severe postoperative pain. It is used by itself or as an adjunct to traditional opioid analgesics. Ketorolac, like other NSAIDs, has analgesic, anti-inflammatory, and antipyretic properties. Unlike morphine or meperidine, ketorolac does not bind to opioid receptors and is not a centrally acting agent. Administered intramuscularly, peak plasma levels are reached in 45 to 50 minutes. It is administered as a 30- or 60-mg intramuscular (IM) loading dose followed by 15- or 30-mg doses IM every 6 hours, with a maximum first-day dose of 150 mg and 120 mg on subsequent days up to a recommended maximum of 5 days. The lower dose range is recommended for elderly patients, patients weighing less than 50 kg, and patients with impaired kidney function. Initial studies show that use of ketorolac decreases the overall amount of opioid analgesia needed for postoperative pain control. To date, reported occurrence of side effects is low. A case study presents a healthy ambulatory surgical patient admitted for inguinal hernia repair using epidural anesthesia. Use of ketorolac has shown initial favorable results. More research is needed to further define its role and side effects in postoperative pain management.

Ambulatory Surgical Procedures

The efficacy of intramuscular ketorolac in combination with intravenous PCA morphine for postoperative pain relief.

STUDY OBJECTIVE: To examine the efficacy of intramuscular (IM) ketorolac used in combination with intravenous (IV) patient-controlled analgesia (PCA) morphine for postoperative pain relief following intra-abdominal gynecologic surgery. DESIGN: Randomized, double-blind, placebo-controlled study. SETTING: Patient care unit at a university medical center. PATIENTS: Thirty-five healthy women undergoing intra-abdominal gynecologic surgery who requested postoperative PCA. INTERVENTIONS: Postoperatively, all patients received IV PCA morphine, with the PCA device programmed to deliver a maximum of 1 mg every 6 minutes (maximum of 30 mg over 4 hours). In addition, patients received one of three regimens: (1) IM saline every 6 hours; (2) IM ketorolac 30 mg while in the postanesthesia care unit (PACU), followed by 15 mg every 6 hours; or (3) IM ketorolac 60 mg while in the PACU, followed by 30 mg every 6 hours. MEASUREMENTS AND MAIN RESULTS: Patients were assessed at regular intervals. Visual analog scale (VAS) scores were used to assess analgesia and patient satisfaction with therapy. Data on morphine usage were obtained from the PCA device, and the frequency and severity of adverse effects were assessed for the presence or absence of side effects. Cumulative morphine dosages were lower (p less than 0.05) in both ketorolac groups at 12, 18, and 24 hours. VAS scores and the frequency of side effects did not differ significantly among groups. CONCLUSIONS: IM ketorolac significantly decreased PCA morphine requirements. The analgesic effects of the two drugs appear to be additive.

Adult

Ketorolac or fentanyl to supplement local anesthesia?

STUDY OBJECTIVE: To evaluate the usefulness of ketorolac in the treatment of intraoperative pain refractory to the administration of local anesthetic alone. DESIGN: Intraoperative acute-pain treatment model consisting of awake, nonsedated patients who randomly received either an opioid or a study drug in a double-blind fashion. SETTING: University medical center. PATIENTS: Eighty patients who underwent breast biopsy, lumpectomy, or central venous catheter placement. INTERVENTIONS: Patients received either ketorolac 1 mg/kg intravenously (IV) up to a total dose of 60 mg or fentanyl 3 micrograms/kg IV up to a total dose of 250 micrograms to supplement the local anesthetic. MEASUREMENTS AND MAIN RESULTS: Verbal pain evaluation and the visual analog scale (VAS) were used for perioperative measurement of pain. Heart rate (HR), blood pressure, and respiratory rate (RR) were recorded before and after analgesic drug injections at 10-minute intervals, both intraoperatively and while the patient was in the postanesthesia care unit (PACU). Speed of recovery was quantified by p-deletion and digit substitution tests on admission to the PACU and at 30-minute intervals until discharge. The frequency of nausea, vomiting, and pruritus were recorded. There were no differences between the groups in perioperative verbal pain evaluation, VAS scores, HR, systolic blood pressure, diastolic blood pressure, or RR. Patients who received ketorolac exhibited a significantly lower frequency of intraoperative and postoperative medication administration intraoperatively, than those who received fentanyl. No additional pain medication was required by patients in the PACU in either group. CONCLUSIONS: Ketorolac is a useful alternative to fentanyl for the treatment of intraoperative pain refractory to the administration of local anesthetic alone during monitored anesthesia care. A decided advantage of ketorolac over fentanyl is the absence of nausea and vomiting in the intraoperative and postoperative periods.

Adult

Comparison of ketorolac and morphine for postoperative pain after major surgery.

This study was designed to determine the relative analgesic efficacy and safety of single intramuscular injections of ketorolac (10 mg or 30 mg) and morphine (10 mg) in patients of either sex with moderate to severe pain after major surgery. In a single-dose, randomised, double-blind study of parallel design, pain was assessed immediately before injection of test medication and at regular intervals for 8 h thereafter. One hundred and seventeen patients (109 undergoing cardiac surgery; 8 lung surgery) were randomized to one of the three treatment groups. Pain intensity was assessed using a 5-point verbal scale before administration of study drugs. Postadministration, at 30 min and hourly for 8 h, pain intensity and pain relief were assessed, again using the 5-point verbal scale. Additionally, as a measure of analgesia, forced expiratory volume (FEV1) was obtained in all patients. Vital signs including blood pressure, pulse, temperature, respiratory rate and blood gases (PaCO2) were recorded prior to and after study medication. Based on hourly pain intensity differences and hourly pain relief observations, ketorolac 10 mg was generally more effective than morphine 10 mg, and ketorolac 30 mg was generally more effective than ketorolac 10 mg. The results of this study show that ketorolac is an effective and safe (with regard to arterial pressure, blood gases and lung function) analgesic for relief of postoperative pain after major surgery in stable patients. No clinically significant adverse effects occurred during the study. One cannot exclude an influence on patients with organ system dysfunction or on parameters not measured in this study.

Adult

Perioperative effects of oral ketorolac and acetaminophen in children undergoing bilateral myringotomy.

Prophylactic administration of analgesics before surgery can decrease the intraoperative anaesthetic requirement and decrease pain during the early postoperative period. In a double-blind, placebo-controlled study involving 90 healthy ASA physical status I or II children undergoing bilateral myringotomy, we compared the postoperative analgesic effects of oral acetaminophen and ketorolac, when administered 30 min before induction of anaesthesia. Patients were randomized to receive saline (0.1 ml.kg-1), acetaminophen (10 mg.kg-1) or ketorolac (1 mg.kg-1) diluted in cherry syrup to a total volume of 5 ml. Anaesthesia was induced and maintained with halothane and nitrous oxide via a face mask. Postoperative pain was assessed by a blinded observer using an objective pain scale. The three study groups were similar with respect to demographic data, duration of anaesthesia and surgery, induction behaviour, oxygen saturation, incidence of postoperative emesis and, recovery times. The ketorolac group had lower postoperative pain scores and required less frequent analgesic therapy in the early postoperative period compared with the acetaminophen and placebo groups. In contrast, there were no differences in pain scores or analgesic requirements between the acetaminophen and the placebo groups. We conclude that the preoperative administration of oral ketorolac, but not acetaminophen, provided better postoperative pain control than placebo in children undergoing bilateral myringotomy.

Acetaminophen

A comparative study of intramuscular ketorolac and pethidine in labour pain.

A single dose block randomised double-blind study comparing intramuscular ketorolac, 50 mg of pethidine and 100 mg pethidine was carried out in multiparous women. Pain intensity and sedation effect were recorded at inclusion to the study, half hourly for the first 2 h, then hourly until 6 h after delivery. Maternal and neonatal side effects were noted including the Apgar scores and the baby's requirements for resuscitation. All three treatments are relatively ineffective in relieving labour pain. There was no difference in the analgesic efficacy between the two doses of pethidine but both doses of pethidine were statistically more effective compared with ketorolac. There was no difference in the retrospective assessment of the three groups or when comparison was made with the previous labour. A similar number of patients required further analgesia in each group. In all three groups, no adverse effect occurred in the mother or fetus. Maternal sedation and fetal depression were statistically less in the ketorolac group. Although ketorolac had inferior analgesic effect, its use was not associated with clinically significant sequelae and it showed a superior safety profile compared with either dose of pethidine. The study was not powerful enough to detect a difference between 50 mg and 100 mg of pethidine.

Adolescent

Ketorolac for sickle cell vaso-occlusive crisis pain in the emergency department: lack of a narcotic-sparing effect.

STUDY OBJECTIVE: To determine if a single dose of intramuscular ketorolac given on presentation to the emergency department has a narcotic-sparing effect in adult patients with sickle cell vaso-occlusive crisis pain. DESIGN: A prospective, randomized, single-dose, double-blind study. SETTING: ED of a university hospital and an affiliated county hospital. TYPE OF PARTICIPANTS: Eighteen adult patients who presented to the ED with sickle cell crisis pain a total of 24 times. INTERVENTIONS: Patients were randomized to receive either ketorolac 60 mg IM or placebo on presentation to the ED. Subjects were administered meperidine on presentation and then received a standardized dose of meperidine every 30 minutes during the four-hour observation period based on the severity of pain. MEASUREMENTS AND MAIN RESULTS: The 12 subjects in the ketorolac group received an average of 231 +/- 92 mg meperidine, whereas the 12 subjects in the placebo group received an average meperidine dose of 250 +/- 85 mg (P = .61). CONCLUSION: The use of intramuscular ketorolac did not lead to a clinically significant reduction in the requirement for narcotics during the four-hour ED treatment period.

Acute Disease

Possible intraoperative anesthetic-sparing effect of parenteral ketorolac.

OBJECTIVE: Because the analgesic effects of ketorolac are equivalent to those of narcotic analgesics, we investigated the possibility that this non-steroidal antiinflammatory drug might also exhibit anesthetic-sparing properties similar to those described for narcotic agents. DESIGN: A nonrandomized, double-blind convenience sample. The treatment group received a preoperative dose of ketorolac 60 mg im 45 minutes prior to the induction of anesthesia. All other preoperative medications were identical. SETTING: Brooke Army Medical Center, a primary care setting. PARTICIPANTS: Six women requiring vaginal hysterectomies from American Society of Anesthesiologists class I/II, all of similar age, weight, and body surface area. OUTCOME MEASURES: End-tidal concentrations of the anesthetic gas were measured at five-minute intervals using a gas analyzer. A mean percent end-tidal concentration versus time curve was generated for each group. RESULTS: The area under the concentration curves for the anesthetic gas in the ketorolac and control group were 15.9 +/- 5.1 and 52.3 +/- 13.4, respectively (p = 0.006). CONCLUSIONS: Ketorolac exhibits an anesthetic-sparing quality similar to that observed with narcotic analgesics.

Aged

Anaphylactoid reaction following ketorolac tromethamine administration.

OBJECTIVE: To report a case of an anaphylactoid reaction to injectable ketorolac tromethamine in a patient with no prior history of allergies or risk factors associated with nonsteroidal anti-inflammatory drug-induced hypersensitivity reactions. CASE SUMMARY: A 37-year-old man without a significant medical history presented to an emergency department with vague, dull, left-sided chest pain. Myocardial infarction was ruled out based on an unremarkable electrocardiogram, chest X-ray, and laboratory data that were within normal limits. Sublingual nitroglycerin 0.4 mg, magnesium/aluminum hydroxide gel 30 mL, and intravenous ranitidine 50 mg were administered without resolution of symptoms. Ketorolac tromethamine 60 mg was administered intramuscularly with resolution of symptoms. The patient was discharged; however, within 30 minutes, he returned to the emergency department with facial swelling, shortness of breath, and chest tightness. Multiple doses of aerosolized albuterol and intravenous methylprednisolone and diphenhydramine were administered, resulting in a slight improvement of symptoms. The patient was admitted for a complete cardiac evaluation that proved negative. The allergic symptoms resolved and the patient was discharged without medication after a three-day hospitalization. DISCUSSION: Ketorolac tromethamine is the first injectable nonsteroidal antiinflammatory drug approved for short-term pain management. A review of the literature revealed no similar cases of anaphylactoid reaction. CONCLUSIONS: Healthcare professionals must be aware of the potential risks of anaphylactoid reactions, especially in light of the increased use of injectable ketorolac in the ambulatory setting and availability of the oral formulation.

Adult

Ketorolac versus meperidine and hydroxyzine in the treatment of acute migraine headache: a randomized, prospective, double-blind trial.

STUDY OBJECTIVE: To compare the effectiveness of IM ketorolac with that of meperidine and hydroxyzine in the treatment of acute migraine headache. DESIGN: Prospective, randomized, double-blind trial. SETTING: Urban emergency department with an annual census of 42,000 patients. PARTICIPANTS: Forty-seven adult patients with migraines enrolled on 50 visits. INTERVENTIONS: Patients were randomly assigned to receive a single injection of either 60 mg ketorolac (group 1) or 100 mg meperidine and 50 mg hydroxyzine (group 2). Pain assessment was made using both visual-analog and verbal descriptor scales. RESULTS: At 60 minutes, 15 patients (60%) from group 1 (25) and 14 patients (56%) from group 2 (25) reported a great deal of complete relief (P = .77) Sixty-minute mean pain relief scores (3.35 versus 3.37) were different (P = .76). Nine patients (36%) from group 1 and seven patients (28%) from group 2 required additional analgesia (P = .76). CONCLUSION: Ketorolac is as effective as meperidine and hydroxyzine for the treatment of acute migraine headache.

Acute Disease