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Clinical Trials/NCT06390007
NCT06390007
Completed
Not Applicable

The Efficacy of Acupuncture in the Management of Postoperative Pain in the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital

Indonesia University1 site in 1 country70 target enrollmentSeptember 12, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Indonesia University
Enrollment
70
Locations
1
Primary Endpoint
Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale
Status
Completed
Last Updated
11 months ago

Overview

Brief Summary

Pain is an unpleasant sensory and emotional experience resulting from tissue damage. Pain management is typically conducted according to the World Health Organization (WHO) pain management ladder. Analgesics administered to pediatric patients vary in dosage and type, but these analgesics often have significant side effects. The acupuncture technique using press needles is a non-pharmacological pain therapy modality that has been studied for its ability to reduce the use of analgesic drugs, thereby potentially decreasing side effects associated with analgesic use.

The study was conducted using a randomized controlled trial (RCT) design involving 70 pediatric postoperative patients aged 1-18 years who were admitted to the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital. Subjects were divided into two groups: a control group and an experimental group. The control group received standard analgesic therapy and sham press needle application (a patch resembling a press needle without a needle), while the experimental group received standard analgesic therapy and press needle application at acupuncture points after the patient had been in the Pediatric Intensive Care Unit for 24 hours. Pain scale monitoring was conducted at 1, 6, 24, 48, and 72 hours using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale for children aged 1-8 years, and the Numeric Rating Scale (NRS) for children over 8 years old.

This study hypothesizes that the acupuncture technique using press needles can reduce the pain scale in pediatric postoperative patients, leading to a decrease in the use of analgesics and a reduction in side effects associated with analgesic use.

Registry
clinicaltrials.gov
Start Date
September 12, 2024
End Date
April 23, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. dr. Irene Yuniar, Sp.A(K)

Lecturer of Indonesia University

Indonesia University

Eligibility Criteria

Inclusion Criteria

  • Pediatric postoperative patients admitted to the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital
  • Aged between 1 and 18 years
  • Patients with a platelet count greater than 20,000/mL
  • Patients undergoing elective surgery
  • Willingness to participate in the study

Exclusion Criteria

  • Patients with a local infection at the puncture site
  • Patients with anatomical abnormalities of the outer ear
  • Failure to complete the acupuncture therapy
  • Patients with chronic illnesses who have previously received analgesic therapy

Outcomes

Primary Outcomes

Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale

Time Frame: Pain scale monitoring will be conducted at 1 hour; 6 hours; 24 hours; 48 hours; and 72 hours after the application of sham press needle / press needle acupuncture

The Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale for children aged 1 to 8 years is used to assess pain levels

Numeric Rating Scale (NRS) pain scale

Time Frame: Pain scale monitoring will be conducted at 1 hour; 6 hours; 24 hours; 48 hours; and 72 hours after the application of sham press needle / press needle acupuncture

The Numeric Rating Scale (NRS) is used to assess pain levels in children over the age of 8.

Behavioral Pain Scale (BPS)

Time Frame: Pain scale monitoring will be conducted at 1 hour; 6 hours; 24 hours; 48 hours; and 72 hours after the application of sham press needle / press needle acupuncture

The Behavioral Pain Scale (BPS) with a range of 3 to 12 for patients on ventilators.

Study Sites (1)

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