Ketamine for Post-operative Analgesia in Hemorrhoidectomy
ConditionHemorrhoids
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Oklahoma
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18-100
Undergoing a hemorrhoidectomy for Grade III or IV hemorrhoids.
Disqualifiers
Inability to undergo general anesthesia
Contraindications to hemorrhoidectomy
History of schizophrenia or other hallucinatory psychiatric illnesses
History of psychosis
Trial design
Design model
Parallel
Treatments tested in this trial
Ketamine
DrugStandard general anesthesia PLUS ketamine will be given for post-operative analgesia
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Intraoperative ketamine infusionActive comparator 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
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.
Time frame
two weeks post-operationSecondary outcomes
1
Change in post-op pain
Wong-Baker FACES Pain Rating Scale, which ranges from 0 to 10, with 0 being represented by a happy face indicating "No Hurt" to 10, represented by a crying face, indicating "hurts like the worst pain imaginable".
Time frame
Post-op days 1, 3, 5, 7, and 10Sponsors and contacts
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Source ClinicalTrials.gov