Intravenous Sub-dissociative Dose Ketamine Injection Versus Infusion for Analgesia in the Emergency Department

Pain Clinical Trial

Official title:

Intravenous Sub-dissociative Dose Ketamine Injection Versus Infusion for Analgesia in the Emergency Department: A Prospective, Randomized, Double-blind Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916927
• Other study ID #: 00002
• Status: Completed
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2020
• Source: Alameda Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: The purpose of this study is to determine if administering ketamine as an intravenous (IV) infusion over 15 minutes, as compared to an IV push, will decrease adverse drug reactions without attenuating its analgesic effects.

Study design: prospective, randomized, controlled, double-blind trial.

Description:

Objective: The purpose of this randomized, controlled, double-blind trial is to evaluate if sub-dissociated dose ketamine given as an infusion versus an intravenous (IV) push over 1 minute has fewer and/or less severe adverse drug reactions and provides equivalent analgesia for patients with moderate to severe pain in the emergency department (ED).

Study design: Prospective, randomized, controlled, double-blind trial

Participants: Research assistants will recruit patients ≥18 years old with moderate to severe pain (NRS≥5) and an anticipated stay in the emergency department ≥1 hour. A sample size calculation was performed based on prior data which suggests that 60% of IV push arm and 20 % of infusion arm will have adverse drug reactions. investigators assume an alpha of 0.05 and a power of 0.8, which results in 56 patients needing to be enrolled.

Intervention: After a trained research assistant obtains written informed consent, pharmacists will randomize the participants to the IV push or IV infusion arm of the study. All patients will be placed on a cardiac monitor. All patients will receive and IV push over 1 minute and a 100 mL normal saline minibag over 15 minutes.

In the IV push arm, pharmacists will provide to the nurse ketamine 0.3 mg/kg in a 10 mL syringe and a 100 mL normal saline minibag. The nurse will start the minibag of normal saline and then administer the IV push of ketamine over 1 minute.

In the IV infusion arm, pharmacists will provide to the nurse ketamine 0.3 mg/kg in a 100 mL normal saline minibag and a 10 mL syringe of normal saline. The nurse will start the minibag of normal saline and then administer the IV push over 1 minute.

Data collection: The trained research assistant will collect data on the patients' pain scores, adverse drug reactions (presence, severity, and how bothersome they are), and vital signs.

Statistical analysis: Investigators will perform descriptive statistics, compare the proportion of patients with side effects, compare the severity of the side effects scores, and compare how bothersome the side effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pain NRS =5

• Anticipated stay in ED =1 hour

Exclusion Criteria:

• Pregnant or breast feeding

• Vital sign abnormalities (SBP <90, SBP > 180, HR < 50, HR > 150, RR <10, RR > 30, weight <45 kg, weight > 115 kg)

• Arrhythmias

• Altered mental status (active psychosis/delirium)

• Administration of opioid pain medication in previous 1 hour

• history of acute head or ocular trauma

• presence of known intracranial mass or vascular lesion

Related Conditions & MeSH terms

• Emergencies
• Pain

Intervention

Drug:
• Ketamine IV Infusion
Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute.
• Ketamine IV push
Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min.

Locations

Country	Name	City	State
United States	Alameda Health System, Highland Hospital	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Alameda Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side Effects	The difference in percentage of participants endorsing side effects between each arm of the study over 60 minutes.	0 - 60 minutes
Secondary	Side Effects	The difference in percentage of participants endorsing side effects between each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes.	5, 10, 15, 20, 30, 45, 60 minutes
Secondary	Side Effect Severity	The difference in severity of side effects (0 - 4) experienced by participants in each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes. 0 indicates no side effects and 4 most severe side effects.	5, 10, 15, 20, 30, 45, 60 minutes
Secondary	How Bothersome Are the Side Effects?	The difference in how bothersome (0, not bothersome, to 4, very bothersome, on the Side Effect Rating Scale for Dissociative Anesthetics "SERSDA") the side effects experienced by participants in each arm of the study are at 5, 10, 15, 20, 30, 45, and 60 minutes.; "0" (no side effects), "1" (weak), "2" (moderate), "3" ("bothersome") to "4" (very bothersome)	5, 10, 15, 20, 30, 45, 60 minutes
Secondary	Reduction in Pain on Numeric Rating Scale.	The difference in pain numeric rating score (NRS 0-10) experienced by participants in each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes.; Pain numeric rating scale from 0 (no pain) to 10 (maximal pain).	5, 10 , 15, 20, 30, 45, 60 minutes