Effects of Preemptive Intravenous Paracetamol and Ibuprofen on Headache and Myalgia in Patients After Electroconvulsive Therapy
Phase: NA
Conditions: Postoperative Pain, Myalgia, Headache
Sponsor: Inonu University

26.09.2018 
 
 
Effects of Preemptive Intravenous Paracetamol and Ibuprofen on Headache and Myalgia 
in Patients after Electroconvulsive Therapy 
 
 
Erol Karaaslan, Asst. Prof. Department of Anesthesiology and Reanimation, Inonu University 
Medical Faculty, Malatya, Turkey 
Sedat Akbas, Asst. Prof. Department of Anesthesiology and Reanimation, Inonu University 
Medical Faculty, Malatya, Turkey 
Ahmet Selim Ozkan, Asst. Prof. Department of Anesthesiology and Reanimation, Inonu 
University Medical Faculty, Malatya, Turkey 
Esra Porgalı Zayman, Asst. Prof. Department of Anesthesiology and Reanimation, Inonu 
University Medical Faculty, Malatya, Turkey 
 
 
 
 
Address all correspondence to: 
Erol Karaaslan, Asst. Prof. Department of Anesthesiology and Reanimation, Inonu University 
Medical Faculty, Malatya, Turkey 
Mail: erkara44@hotmail.com 
Phone Number: +905322034830 

26.09.2018 
 
 
Study Protocol 
After approval from the Ethics Committee of Inonu University Medical Faculty, study was performed for 60 
patients scheduled for an elective Electroconvulsive Therapy (ECT) under general anesthesia. Patients with 
American Society of Anesthesiologists (ASA) scores I or II and between 18-65 years were randomized to receive 
ECT 3 times a week for treatment of major depression to complete an average of 6 to 12 ECT sessions. The first 
3 ECT sessions were included in the study. Patients with ASA scores III/IV, under the age of 18, over the age of 
65, myocardial infarction, congestive heart failure, pulmonary disease, stroke history, bleeding disorder, hepatic 
and renal dysfunction, pregnant, migraine history, allergy of nonsteroidal anti-inflammatory drugs, parasetamol, 
propofol, neuromuscular disease, peptic ulcer disease, intracranial hypertension, glaucoma and patients who did 
not give informed consent were excluded from the study. After obtaining written informed consent from the 
patients, the study was conducted in accordance with the Declaration of Helsinki. The patients were divided 
randomly and double blind into three groups: Group K (control, saline, n=20), Group P (paracetamol, n=20) and 
Group I (ibuprofen, n=20). 
All patients were informed about the study procedure and the visual analog scale (VAS: a 10-cm scale where 0 = 
no pain and 10 = unbearable pain). No premedication was given to the patients. Preemptive analgesics (ibuprofen 
800 mg IV, paracetamol 20 mg.kg-1 mg IV) were administered to the patients 60 minutes prior to the ECT 
procedure. Patients were taken to the operating room. Standard monitoring with noninvasive blood pressure 
(NIBP), heart rate (HR), peripheral oxygen saturation (SpO2) and electrocardiography (ECG) was performed to 
all. After opening the peripheral vein, standard anesthesia protocol was performed by experienced anesthesiologist 
to all patients via intravenous route; propofol 2-2,5 mg/kg, succinylcholine 1 mg/kg. A bite block was inserted 
prior to treatment to prevent tongue bite and to protect the patient’s teeth. 
Atropine (0.015 mg kg-1) was administered in patients with severe bradycardia during and after ECT, and esmolol 
(0,5 mg kg-1, bolus) was administered in patients with severe hypertension and tachycardia. 
In patients who did not experience complications after the procedure, patients were transferred to the postoperative 
care unit. Patients with hemodynamically stable and adequate spontaneous breathing (saturation> 97%) were taken 
to the post-anesthesia care unit. ECG, pulse oximetry and NIBP monitoring were performed. 100% O2 (5-6L / 
min) was given by nasal cannula. After following up for approximately 1 hour, patients were transferred to the 
psychiatry service when they achieved a score of 9 or higher on the Modified Aldrete score (range 0 –12; scores 
of 9 and above indicate that the patient can be discharged from the PACU). 

26.09.2018 
 
 
 
Patients were evaluated for pain intensity using a visual analogue scale (VAS) score (from 0 to 10, 0=no pain and 
10=the worst pain imaginable). Heart Rate (HR), Systolic Arterial Pressure (SAB), Diastolic Arterial Pressure 
(DAB), Mean Arterial Pressure (OAB), and Respiratory rate (RR/min) were perioperatively recorded at T0 (5 min 
before the procedure), T1 (3 min after the anesthesia induction), T2 (post-seizure), T3 (5 min after the procedure). 
Postoperative side effects (presence of nausea, vomiting and pruritus), VAS (myalgia) and VAS (headache) were 
postoperatively recorded by trained nurses at T4 (postop 2nd hour), T5 (postop 4th hour), T6 (postop 6th hour), 
T7 (postop 12th hour), T9 (postop 24th hour). The duration and severity of seizure were also recorded. 
Statistical Analysis 
 
Statistical analysis were carried out by using SPSS program (SPSS for Windows version 22). ANOVA Test were 
used for the comparison between groups. Correlation analysis was based on the calculation of Pearson’s rank 
correlation coefficients. Value of p below 0.05 was considered as statistically significant. Consent to conduct the 
study was obtained from Local Ethic Committee of Inonu University