The Efficacy of Acupuncture in the Management of Postoperative Pain in the Pediatric Intensive Care Unit

May 14, 2025 updated by: Dr. dr. Irene Yuniar, Sp.A(K), Indonesia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • RSUPN Dr. Cipto Mangunkusumo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
In the control group, standard analgesic therapy will be administered by the attending physician, and a sham press needle (a patch resembling a press needle without a needle) will be applied.
Device: Sham press needle
The plester used is a round plaster that resembles the shape of an acupuncture press needle.
Other Names:
  • plesterin
Experimental: Intervention group
In the experimental group, standard analgesic therapy will be administered and press needle acupuncture will be applied at acupuncture points.
Device: Press needle acupuncture
Press needle acupuncture is a modality of acupuncture using tiny and very thin needles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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.
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2024

Primary Completion (Actual)

March 22, 2025

Study Completion (Actual)

April 23, 2025

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24916

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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