Intranasal ketorolac for acute postoperative pain.
BACKGROUND
Efficacy and tolerability of intranasal ketorolac (SPRIX(R)) was assessed in abdominal surgery patients.


METHODS
Adult patients were randomly assigned to receive ketorolac 31.5 mg (n = 214) or placebo (n = 107) every 6 hr after surgery for 48 hr, then up to 4 times/day for up to 5 days. Morphine sulfate via patient controlled analgesia was available in both groups as needed.


RESULTS
Least square mean 6 hr summed pain intensity difference scores were significantly greater in the ketorolac group indicating better analgesic efficacy compared to placebo (117.4 vs. 89.9, p = 0.032; difference 27.6, 95% CI 2.5-52.7). Pain intensity difference indicated significantly better pain relief in the ketorolac group at 20 min after the first dose (p = 0.01). Morphine use over 48 hr decreased 26% in the ketorolac group compared to placebo (p = 0.004). Day 1 global pain control scores were significantly higher in the ketorolac group compared to placebo (p = 0.009). Quality of analgesia was rated significantly higher (p = 0.009) in the ketorolac group by 20 min after first dose. Adverse event and serious adverse event incidences were similar in both groups. Rhinalgia and nasal irritation, generally mild and transient in nature, occurred more frequently in the ketorolac group.


CONCLUSIONS
Intranasal ketorolac was well tolerated and provided effective pain relief within 20 minutes with reduced opioid analgesia use. While IN ketorolac was assessed in an inpatient, conventional surgery setting in this study, IN ketorolac use may have more relevance for use in outpatient settings and ambulatory surgery or fast-track surgical procedures.
Singla
Neil
N
Lotus Clinical Research/Huntington Hospital, Pasadena, CA 91105, USA.
Singla
Sonia
S
Minkowitz
Harold S
HS
Moodie
John
J
Brown
Colin
C
D000005:Abdomen / Q000601:surgery; D000208:Acute Disease; D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D016058:Analgesia, Patient-Controlled; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D020910:Ketorolac / Q000008:administration & dosage* / Q000009:adverse effects; D016018:Least-Squares Analysis; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage* / Q000009:adverse effects; D010149:Postoperative Pain / Q000188:drug therapy*; D017060:Patient Satisfaction; D010919:Placebos; D055815:Young Adult
D000701:Analgesics, Opioid; D000894:Anti-Inflammatory Agents, Non-Steroidal; D010919:Placebos; D009020:Morphine; D020910:Ketorolac