Phase 4
Completed N=116
Low Dose Ketamine as an Adjunct to Opiates for Acute Pain in the Emergency Department
Source: ClinicalTrials.gov NCT02489630 ↗Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Change in Level of Pain Control as Reported on the NRS-11 — 9.38; 9.44; 7.51; 8.10 Units on a scale (1-10)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study investigates the use of low doses of ketamine, along with opiate pain medication, is more effective at controlling the acute pain of patients in the emergency department than opiate pain medication alone. In addition, this study examines whether patients treated with low doses of ketamine, along with opiate pain medication, will require less opiate pain medication to control their pain, and whether these patients are equally happy with their pain control as patients who receive only opiate pain medication.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Level of Pain Control as Reported on the NRS-11 |
9.38; 9.44; 7.51; 8.10; 5.25; 2.27 | — |
| PRIMARY Change in Patient Satisfaction With Pain Control on a 1-4 Likert Scale |
2.09; 2.27; 2.38; 2.33; 2.54; 2.38 | — |
| SECONDARY Difference in Opiate Dosage Between Study Arms in Morphine Equivalents |
5.41; 5.83; 9.95; 12.81 | — |
Eligibility Criteria
Inclusion Criteria
- Greater than 18 years but less than 70 years old.
- Exhibiting pain defined on a numerical rating scale (NRS-11 [Farrar et al. 2001]) score of equal to or greater than 6 out of 10
- Deemed by the treating EM physician to require opioid analgesia.
Exclusion Criteria
- Respiratory, hemodynamic or neurologic compromise, as determined by observation of signs of respiratory distress, systolic blood pressure less than 90 mmHg or systolic/diastolic blood pressure greater than 160/90, or a Glasgow -Coma Score less than 15.
- A history of chronic ventilation, dialysis or with previously diagnosed cirrhosis or hepatitis by istory.
- Active psychosis.
- Clinical intoxication.
- Known sensitivity to any study drug.
- An inability to understand the NRS-11 pain measurement scale.
- Presentation with headache or chest pain.
- Pregnancy.
- A lack of decision-making capacity.
- A pain score less than 6 on the NRS-11 scale.
- A concern by the treating physician or study personnel of current or prior history of narcotic abuse, or other secondary gain.
- Previously participated in the study.
Data sourced from ClinicalTrials.gov (NCT02489630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.