To evaluate the effect of electroacupuncture on pain, nausea severity and hemodynamic profile in tonsilectomy
Design
Clinical trial with control group, parallel groups, double blind, randomized with 64 patients
Settings and conduct
Patients are candidates for tonsillectomy surgery at Rasoul Akram Hospital. Participants were randomly assigned to two groups. Patients and outcome assessor are blinded to the assignments.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children candidate for tonsillectomy without adenoidectomy. Exclusion criteria: Coagulopathy or upper airway tract infection
Intervention groups
Intervention group: After induction of anesthesia and intubation, needling is performed at four points of Li4, P6, Sp1 and Sp6 by the acupuncturist. The needles remain in place for 20 minutes and stimulated with electroacupuncture.
Control group:Induction of anesthesia and intubation without needling
Main outcome variables
Pain, Nausea severity, Mean arterial pressure, heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101026005026N12
Registration date:2020-03-13, 1398/12/23
Registration timing:prospective
Last update:2020-03-13, 1398/12/23
Update count:0
Registration date
2020-03-13, 1398/12/23
Registrant information
Name
Masood Mohseni
Name of organization / entity
Rasul Akram hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2326
Email address
mohseni@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of electroacupuncture on hemodynamic profile, postoperative pain, nausea and bleeding in pediatric tonsillectomy
Public title
The effect of acupuncture on pain, nausea and bleeding in tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children candidate for tonsillectomy without adenoidectomy
Exclusion criteria:
coagulopathy
upper respiratory tract infection
Age
From 5 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were randomly allocated into acupuncture and control groups using a table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and outcome assessor (in the recovery room) are unaware of assignments.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Next to Milad Tower, Hemat Highway ,Tehran
City
Tehran
Province
Tehran
Postal code
14496-14535
Approval date
2019-12-24, 1398/10/03
Ethics committee reference number
IR.IUMS.FMD.REC.1398.423
Health conditions studied
1
Description of health condition studied
Pediatric tonsillectomy
ICD-10 code
J03
ICD-10 code description
Acute tonsillitis
Primary outcomes
1
Description
Mean arterial pressure
Timepoint
Before, 30-60-90-120-180 minutes after induction
Method of measurement
Digital barometer
2
Description
Heart rate
Timepoint
Before, 30-60-90-120-180 minutes after induction
Method of measurement
Digital barometer
3
Description
Pain
Timepoint
after being fully awake at the recovery
Method of measurement
NRS (Numerical rating scale)
4
Description
Nausea severity
Timepoint
after being fully awake at the recovery
Method of measurement
NRS (Numerical rating scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After induction of anesthesia and intubation, needling is performed at four points of Li4, P6, Sp1 and Sp6 by the acupuncturist. The needles remain in place for 20 minutes and electrically stimulated .
Category
Treatment - Surgery
2
Description
Control group: Induction of anesthesia and maintenance of anesthesia without needling