Clinical trial NCT06390007: The Efficacy of Acupuncture in the Management of Postoperative Pain in the Pediatric Intensive Care Unit
Official title: The Efficacy of Acupuncture in the Management of Postoperative Pain in the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Pediatric Disorder
Acupuncture
Acupuncture, Ear
Pediatric Intensive Care Unit
Keywords: Acupuncture
Postoperative pain
Pediatric Intensive Care Unit
Press needle
Pain therapy
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale
timeFrame: 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
measure: Numeric Rating Scale (NRS) pain scale
timeFrame: 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
measure: Behavioral Pain Scale (BPS)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RSUPN Dr. Cipto Mangunkusumo
state: DKI Jakarta
Study officials:
References: