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Ketamine Effects as Preemptive Analgesia

Effects of Ketamine 0.5 Mg/Kgbw Administration as Preemptive Analgesia on Analgesia Duration and the Need for Fentanyl Following Hysterectomy Surgery

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06040060
Enrollment
40
Registered
2023-09-15
Start date
2022-12-27
Completion date
2023-03-03
Last updated
2023-09-22

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

Conditions

Pain, Postoperative

Keywords

Ketamine, Preemptive Analgesia

Brief summary

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

Interventions

DRUGKetamine

The intervention was prepared by the research team (anesthesia resident) in the form of ketamine which had been diluted to a dosage of 10 mg/cc, taken according to the required dose based on actual body weight then diluted with 0.9% NaCl to 10 cc. Then the two solutions were given to researchers without knowing the contents of the drugs that had been prepared by the resident who assisted in this research.

OTHERPlacebo

While the 0.9% NaCl solution was used as placebo was prepared in a 10 cc syringe

Sponsors

Universitas Padjadjaran
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of postoperative analgesia24 hours post operativeTime interval from completion of hysterectomy until additional analgesic is needed, namely fentanyl 25 µg via PCA
Total need for post-operative analgesic rescue24 hours post operativeThe total amount of rescue analgetic required by research subjects, during the 24 hours after surgery, was given via PCA

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026