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Ketamine Effects as Preemptive Analgesia

U

Universitas Padjadjaran

Status and phase

Completed
Phase 3
Phase 2

Conditions

Pain, Postoperative

Treatments

Other: Placebo
Drug: Ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT06040060
AN-202309.02

Details and patient eligibility

About

The goal of this randomized controlled trial is to compare the effect of preemptive ketamine administration to placebo administration in patients underwent hysterectomy surgery. The main questions it aims to answer are:

  1. To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on the duration of analgesia after hysterectomy surgery
  2. To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on the need for fentanyl after hysterectomy surgery

Enrollment

40 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients aged 18-50 years.
  2. ASA I and II physical status (American Society of Anesthesiologists).

Exclusion criteria

  1. The patient is not willing to be included as a research subject
  2. The patient takes anti-pain medication before surgery
  3. History of allergies to the drugs to be used
  4. History of chronic pain

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

Preemptive Ketamine
Active Comparator group
Description:
Preemptive administration of Ketamine 0.5 mg/kgBB intravenously, given 10 minutes prior to incision
Treatment:
Drug: Ketamine
Placebo
Placebo Comparator group
Description:
Placebo administration of 10 mL NaCl 0,9% intravenously, given 10 minutes prior to incision
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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