A Comparison of Ketamine Infusion Versus Placebo in Opioid Tolerant and Opioid Naive Patients After Spinal Fusion

NCT03274453 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 12-02202
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the proposed study is to examine the effectiveness of low dose postoperative ketamine infusion as an analgesic adjuvant to morphine pca in opioid tolerant and opioid naïve patients after major spine surgery. Primary endpoints of the study are to determine the effectiveness of postoperative ketamine infusion in for the reduction of postoperative pain and opioid requirements.

Conditions

Spinal Fusion

Outcome Measures

Primary Outcomes (1)

• Hydromorphone Use/24 Hours postOP in mg/kg

  Hydromorphone use during the first postoperative 24 hours in mg/kg

  24 Hours

Study Arms (4)

Ketamine Naive

ACTIVE COMPARATOR

After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine. Infusion will be maintained for 24 hours.

Drug: Ketamine

Naive Placebo

PLACEBO COMPARATOR

Saline will be administered at the same rate as the ketamine infusion. Infusion will be maintained for 24 hours.

Drug: Saline

Tolerant Placebo

PLACEBO COMPARATOR

Saline will be administered at the same rate as the ketamine infusion. Infusion will be maintained for 24 hours.

Drug: Saline

Tolerant Ketamine

EXPERIMENTAL

After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine. Infusion will be maintained for 24 hours.

Drug: Ketamine

Interventions

Ketamine DRUG

0.12 mg/kg/hr of ketamine post surgery

Ketamine Naive; Tolerant Ketamine

Saline DRUG

Saline will be administered at the same rate as the ketamine infusion.

Naive Placebo; Tolerant Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult and teenage (\>/=16) male or female who will undergo surgery for multilevel (\>4 level) spinal fusion from a posterior approach with general anesthesia, and who are fluent English speakers such that they can complete the pain score and satisfaction questionnaires whose scores are a critical outcome variable.
• If female, subject is non-lactating and is either:
• Not of childbearing potential
• Of childbearing potential but is not pregnant at time of baseline as determined by pre-surgical pregnancy testing.
• Subject is ASA physical status 1, 2, or 3.

You may not qualify if:

• anxiety
• psychiatric disorder
• Allergy or sensitivity to ketamine or dilaudid
• Deemed un-acceptable by study team
• Cognitively impaired (by history)
• Subject requires chronic antipsychotic medication
• Subject known to be in liver failure
• Subject for whom opioids or ketamine are contraindicated
• Patients with narrow angle glaucoma
• Patients with a history of psychosis

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

• Boenigk K, Echevarria GC, Nisimov E, von Bergen Granell AE, Cuff GE, Wang J, Atchabahian A. Low-dose ketamine infusion reduces postoperative hydromorphone requirements in opioid-tolerant patients following spinal fusion: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jan;36(1):8-15. doi: 10.1097/EJA.0000000000000877.

  PMID: 30113350 DERIVED

MeSH Terms

Interventions

Ketamine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Kirsten Boenigk
• Organization: New York University School of Medicine

Kirsten.Boenigk@nyumc.org

212 598 6085

Study Officials

• Kirsten Boenigk, MD

  Kirsten.Boenigk@nyumc.org

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 7, 2017
• Study Start: November 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: September 1, 2017
• Last Updated: June 14, 2018
• Results First Posted: June 14, 2018

Record last verified: 2018-05

Locations

US (1)