NCT04129086: KAPT

Ketamine for Acute Pain Management After Trauma

Completed Phase 4 Results posted Last updated 21 April 2023

What this trial tests

Phase 4 trial testing Ketamine plus usual care in Trauma Injury in 305 participants. Completed in 30 September 2022.

Timeline

1 July 2020

Primary endpoint
30 March 2022

30 September 2022

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	305
Start date	1 July 2020
Primary completion	30 March 2022
Estimated completion	30 September 2022
Sites	1 location across United States

Drugs / interventions tested

• Ketamine plus usual care — full drug profile →
• Usual Care

Conditions studied

• Trauma Injury — all drugs for Trauma Injury →
• Pain — all drugs for Pain →
• Opioid Use — all drugs for Opioid Use →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

16 and older, any sex, with Trauma Injury or Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day Primary · In-hospital days (up to 6 weeks post hospital admission)

Group	Value	95% CI
Ketamine Plus Usual Care	32	29 – 36
Usual Care	39	35 – 44

Number of Patients That Showed Signs of Delirium During In-hospital Stay Secondary · Hospital discharge (up to 6 weeks post hospital admission)

Incidence of delirium during in-hospital stay

Group	Value	95% CI
Ketamine Plus Usual Care	16
Usual Care	9

Number of Patients That Required Unplanned Intubation During In-hospital Stay Secondary · Hospital discharge (up to 6 weeks post hospital admission)

incidence of need for unplanned intubation during in-hospital stay

Group	Value	95% CI
Ketamine Plus Usual Care	2
Usual Care	3

Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay Secondary · Hospital discharge (up to 6 weeks post hospital admission)

Incidence of need for unplanned admission to an ICU

Group	Value	95% CI
Ketamine Plus Usual Care	7
Usual Care	7

Duration of Ketamine Drip Secondary · Hospital discharge (up to 6 weeks post hospital admission)

Length of time Ketamine drip was infused

Group	Value	95% CI
Ketamine Plus Usual Care	60	32 – 86
Usual Care	76	31 – 94

Number of Patients Requesting to Discontinue Ketamine Secondary · Hospital discharge (up to 6 weeks post hospital admission)

Number of patients requesting to stop Ketamine for any complaint

Group	Value	95% CI
Ketamine Plus Usual Care	9
Usual Care	0

Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch Secondary · Hospital discharge (up to 6 weeks post hospital admission)

Incidence of use of additional pain control adjuncts such as regional anesthesia and lidocaine patch during hospitalization

Regional anesthesia

Group	Value	95% CI
Ketamine Plus Usual Care	16
Usual Care	20

Lidocaine drip

Group	Value	95% CI
Ketamine Plus Usual Care	0
Usual Care	0

Ventilator Free Days Secondary · Hospital discharge (up to 6 weeks post hospital admission)

Number of inpatient hospital days patients did not require mechanical ventilation

Group	Value	95% CI
Ketamine Plus Usual Care	30	29 – 30
Usual Care	30	29 – 30

ICU Free Days Secondary · Hospital discharge (up to 6 weeks post hospital admission)

Number of inpatient hospital days patients did not require ICU level of care

Group	Value	95% CI
Ketamine Plus Usual Care	29	26 – 30
Usual Care	28	26 – 30

Hospital Free Days Secondary · 30 days post admission

Number of days patients were not in the hospital during the first 30 days after admission

Group	Value	95% CI
Ketamine Plus Usual Care	20	13 – 25
Usual Care	21	13 – 25

Number of Patients Discharged From the Hospital With an Opioid Prescription Secondary · Hospital discharge (up to 6 weeks post hospital admission)

Number of patients discharged from the hospital with an opioid prescription

Any Opioid at discharge

Group	Value	95% CI
Ketamine Plus Usual Care	82
Usual Care	97

Tramadol

Group	Value	95% CI
Ketamine Plus Usual Care	72
Usual Care	81

Hydrocodone

Group	Value	95% CI
Ketamine Plus Usual Care	3
Usual Care	2

Oxycodone

Group	Value	95% CI
Ketamine Plus Usual Care	10
Usual Care	15

Codeine

Group	Value	95% CI
Ketamine Plus Usual Care	1
Usual Care	3

Methadone

Group	Value	95% CI
Ketamine Plus Usual Care	0
Usual Care	0

Fentanyl patch

Group	Value	95% CI
Ketamine Plus Usual Care	0
Usual Care	0

Hydromorphone

Group	Value	95% CI
Ketamine Plus Usual Care	0
Usual Care	0

Number of Patients Who Reported Continued Pain Continued Post-traumatic Pain at 6 Months Post Admission Secondary · 6 months post admission

Number of patients who reported continued pain at 6 months following trauma injury

Group	Value	95% CI
Ketamine Plus Usual Care	78
Usual Care	71

Sponsor's own description

The purpose of this study is to compare the effectiveness of Ketamine drip along with usual care and usual care alone on trauma patients and to longitudinally quantify the pain experience of patients during hospitalization.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ketamine for acute pain after trauma: A pragmatic, randomized clinical trial.
   Klugh JM, Puzio TJ, Wandling MW, Guy-Frank CJ, et al · · 2024 · cited 3× · PMID 38689402 · DOI 10.1097/ta.0000000000004325
2. Ketamine for acute pain after trauma: the KAPT randomized controlled trial.
   Puzio TJ, Klugh J, Wandling MW, Green C, et al · · 2022 · cited 1× · PMID 35897081 · DOI 10.1186/s13063-022-06511-6
3. Ketamine for Acute Pain After Trauma: KAPT Trial
   Puzio TJ, Klugh J, Wandling MW, Green C, et al · · 2021 · DOI 10.21203/rs.3.rs-604124/v1