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

Not Applicable

Completed

• Conditions: Pain, Postoperative; Pediatric Disorder; Acupuncture; Acupuncture, Ear; Pediatric Intensive Care Unit
• Interventions: Device: Sham press needle; Device: Press needle acupuncture

• Registration Number: NCT06390007
• Lead Sponsor: Indonesia University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-29
• Study Start: 2024-09-12
• Primary Completion: 2025-03-22
• Study Completion: 2025-04-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Sham press needle	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.
Intervention group	Press needle acupuncture	In the experimental group, standard analgesic therapy will be administered and press needle acupuncture will be applied at acupuncture points.

Primary Outcome Measures

Name	Time	Method
Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale	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	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)	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.

Trial Locations

Locations (1)

RSUPN Dr. Cipto Mangunkusumo; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia