DEM Journal Club Report

1. Host/Presenter/Date:

   Dr. Talbot /Dr. Chandra/ March

2. Title of paper/citation:

Sergey Motov, et al. Comparison of Intravenous Ketorolac at Three Single-Dose Regimens for Treating Acute Pain in the Emergency Department: an RCT. Ann Emerg Med. 2017; 70:177-84.

3. Research question/PICOD

Question: Does increasing the dose of intravenous Ketorolac improve analgesia in emergency department patients with a variety of pain syndromes?

Population: 240 patients, 80 allocated to each group

Adult patients (18-65) who presented to the emergency department with acute (less than 30 d) moderate to severe (intensity of 5 or greater on a standard 0-10 pain scale) flank, abdominal, musculoskeletal, or headache pain, who would routinely be treated with ketorolac by the attending emergency physician.

(Exclusion criteria: Older than 65 yrs, pregnancy or breastfeeding, active PUD, acute GI hemorrhage, history of renal or hepatic disease, allergy to NSAIDs, unstable vitals systolic BP <90 or > 180 mmHg or HR < 50 or > 150, and patients that had already received analgesic.

Intervention (1): Ketorolac 10 mg IV  (given over 1-2 minutes)

Intervention (2): Ketorolac 15 mg IV (given over 1-2 minutes)

Intervention (3):  Ketorolac 30 mg IV (given over 1-2 minutes)

Patients who still desired pain medications after 30 minutes were offered Morphine 0.1 mg/kg IV as a rescue analgesic.

Outcome:  Primary: Reduction in the numeric pain scale score at 30 minutes from medication administration

Secondary: Rates and percentage of subjects experiencing adverse events or requiring rescue analgesia.

Design: Randomized control trial

4. Results

Patients in all dosing regimens had clinically significant improvement in their pain scores after 30 min. The reduction in pain persisted through to 120 minutes.

There was no difference in the rate of rescue morphine use by group over time.

There was no difference in the common adverse effects (dizziness 18% vs 20% vs 15%, nausea 11% vs 14% vs 10%, headache 10% vs 2.5% vs 3.8%, itching 0% vs 1.3% vs 1.3%, or flushing 0% vs 1.3% vs 0%).

Other more serious side effects were not documented (gastrointestinal bleeding, renal impairment, changes in bleeding times). There are other studies that suggest that some of these adverse effects are dose related and therefore lower doses would be expected to reduce these complications.

5. Authors conclusions

Ketorolac had similar analgesic efficacy profiles at doses of 10 mg, 15 mg and 30 mg IV for short term treatment of acute moderate to severe pain in the Emergency Department.  The results of the study provide a basis for changes in practice patterns and guidelines in the Emergency Department supporting the use of the 10 mg IV ketorolac dose.

6. Discussion at Journal Club

   1. Strengths
      1. Randomized control blinded design
      2. Excellent data collection for primary outcome (99%)

• Groups were treated the same

1. Weakness
   1. Single center
   2. Although randomized, the patients were also only recruited between 8 am and 8 pm Monday to Friday as a convenience sample. This could lead to selection bias.

• Although the patient, nurse, research coordinator, research fellow and the physicians were blinded to the group allocation, the pharmacist, research manager and the statistician were aware of patient allocation.

7. Bottom line/suggested change to practice/actions

Patients presenting to the emergency department with moderate to severe pain receiving a single dose of intravenous Ketorolac had a significant reduction in pain with no difference between the dosing regimens of 10mg, 15 mg and 30 mg IV.

We recommend a change to our renal colic protocol and our ED Assessment order set to administer Ketorolac 10 mg IV instead of 30 mg IV of the treatment of a variety of conditions with moderate to severe pain. Unfortunately, the Ketorolac used in the emergency department comes in a 30 mg/ml vial. It is more efficient to draw up the full dose for each individual patient than be taking 1/3 of a ml out and possibly throwing the remainder out. Recommend asking Emergency Department pharmacist to determine if other solution strengths are available. Ketorolac could be a narcotic sparing analgesic, where in the opinion of the attending physician, appropriate patients can be given ketorolac and then reassessed at 30 minutes and rescue mediation given as required.