Ketamine Effects as Preemptive Analgesia

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06040060
• Other study ID #: AN-202309.02
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 27, 2022
• Est. completion date: March 3, 2023

Study information

• Verified date: September 2023
• Source: Universitas Padjadjaran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 3, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Ketamine
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.

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

Locations

Country	Name	City	State
Indonesia	Universitas Padjadjaran	Bandung	West Java

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Padjadjaran

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of postoperative analgesia	Time interval from completion of hysterectomy until additional analgesic is needed, namely fentanyl 25 µg via PCA	24 hours post operative
Primary	Total need for post-operative analgesic rescue	The total amount of rescue analgetic required by research subjects, during the 24 hours after surgery, was given via PCA	24 hours post operative