NCT04248205

Brief Summary

This is a prospective, randomized study of ketamine versus no ketamine in approximately 100 patients undergoing hemorrhoidectomy for Grade III or IV hemorrhoids. The participants will be blinded to which treatment arm they are assigned, because participants will be under anesthesia when the ketamine is administered. The investigators will know whether the participant receives ketamine or not.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
14mo left

Started Jun 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jun 2020Jul 2027

First Submitted

Initial submission to the registry

January 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

6.6 years

First QC Date

January 27, 2020

Last Update Submit

March 26, 2026

Conditions

Hemorrhoids

Keywords

hemorrhoidectomyketaminepost operative pain

Outcome Measures

Primary Outcomes (1)

  • Change in post-operative narcotic usage

    Standardized pain control regimen with ketamine; at two week surgical follow-up visit patient will bring their oxycodone prescription and we will count the number of pills that were taken.

    two weeks post-operation

Secondary Outcomes (1)

  • Change in post-op pain

    Post-op days 1, 3, 5, 7, and 10

Study Arms (2)

Intraoperative ketamine infusion

ACTIVE COMPARATOR

Subjects in this group will receive standard anesthesia during surgery and a dose of ketamine at 0.3 mg/kg IV bolus prior to surgical incision. If the procedure lasts more than 1 hour, an additional bolus dose will be given.

Drug: Ketamine

Control group

NO INTERVENTION

This group will only receive the standard anesthesia during surgery with no ketamine.

Interventions

KetamineDRUG

Standard general anesthesia PLUS ketamine will be given for post-operative analgesia

Intraoperative ketamine infusion

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-100
  • Undergoing a hemorrhoidectomy for Grade III or IV hemorrhoids.

You may not qualify if:

  • Inability to undergo general anesthesia
  • Contraindications to hemorrhoidectomy
  • History of schizophrenia or other hallucinatory psychiatric illnesses
  • History of psychosis
  • Chronic narcotic usage defined as either having a pain contract with a pain management specialist and no narcotic usage for one month prior to hemorrhoidectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Related Publications (3)

  • Himmelseher S, Durieux ME. Ketamine for perioperative pain management. Anesthesiology. 2005 Jan;102(1):211-20. doi: 10.1097/00000542-200501000-00030. No abstract available.

    PMID: 15618805BACKGROUND

  • Gorlin AW, Rosenfeld DM, Ramakrishna H. Intravenous sub-anesthetic ketamine for perioperative analgesia. J Anaesthesiol Clin Pharmacol. 2016 Apr-Jun;32(2):160-7. doi: 10.4103/0970-9185.182085.

    PMID: 27275042BACKGROUND

  • Luggya TS, Roche T, Ssemogerere L, Kintu A, Kasumba JM, Kwizera A, Tindimwebwa JV. Effect of low-dose ketamine on post-operative serum IL-6 production among elective surgical patients: a randomized clinical trial. Afr Health Sci. 2017 Jun;17(2):500-507. doi: 10.4314/ahs.v17i2.25.

    PMID: 29062346BACKGROUND

MeSH Terms

Conditions

HemorrhoidsPain, Postoperative

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Steven N Carter, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven N Carter, MD

CONTACT

405-271-8001steven-carter@ouhsc.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2020

First Posted

January 30, 2020

Study Start

June 15, 2020

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)