the effect of perianal injection of dexmedetomidine compared to the effect of ketamine on the postoperative pain and vomiting of perianal fistula

Investigating the effect of perianal injection of dexmedetomidine compared to the effect of ketamine on the postoperative pain and vomiting of perianal fistula: a triple-blind randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230912059416N1

Enrollment

102

Registered

2023-11-11

Start date

2023-12-06

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute pain. Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified General symptoms and signs Pain, not elsewhere classified Acute pain

Interventions

Intervention 1: Control group: No medicine is injected subcutaneously in the perianal area after surgery. Intervention 2: Intervention group: In this group of patients, 1.5 micrograms/kg of dexmedetom

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 70 years Candidate for pre-anal surgery (pre-anal fistula) American Society of Anaesthesiology (ASA) class II and I Informed consent

Exclusion criteria

Exclusion criteria: Advanced diabetes leads to neuropathy Neuromuscular diseases Psychological and neurological diseases Drug addiction Taking any analgesic or nonsteroidal anti-inflammatory drug(NSAID) in the last 24 hours Pregnancy Body Mass Index(BMI) greater than 30 Preoperative HR less than 60 2nd and 3rd degree atrioventricular (AV) block Taking antihypertensive drugs including Methyldopa, Clonidine and other Alpha2 Adrenergic Agonists Abnormal liver function tests Lung problems High blood pressure Alcoholism Taking N-Methyl-D-Aspartate (NMDA) Antagonists/Memantin History of seizures, high Intraocular pressure (IOP) or Intracranial pressure (ICP) History of sensitivity to ketamine or dexmedetomidine drugs in previous surgeries Chronic pain

Design outcomes

Primary

Measure	Time frame
Intensity of pain. Timepoint: After the operation in hours 1, 3, 6, 12, and 24. Method of measurement: The Visual Analogue Scale (VAS).	—

Secondary

Measure	Time frame
Time required for the first dose of analgesic. Timepoint: After the operation in hours 1, 3, 6, 12 and 24. Method of measurement: The time interval between the first injection of analgesic with the patient's operation.;Total analgesic dose received. Timepoint: 24 hours after the operation. Method of measurement: Total analgesic doses received during the last 24 hours.;Patient vomiting. Timepoint: After the operation in hours 1, 3, 6, 12 and 24. Method of measurement: The frequency of vomiting after the operation.	—

Measure

Time frame

Time required for the first dose of analgesic. Timepoint: After the operation in hours 1, 3, 6, 12 and 24. Method of measurement: The time interval between the first injection of analgesic with the patient's operation.;Total analgesic dose received. Timepoint: 24 hours after the operation. Method of measurement: Total analgesic doses received during the last 24 hours.;Patient vomiting. Timepoint: After the operation in hours 1, 3, 6, 12 and 24. Method of measurement: The frequency of vomiting after the operation.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Farshid reza Mirsayah

Mashhad University of Medical Sciences

Mirsayyahf4001@mums.ir+98 51 3840 0001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026