Safety and Efficacy of Oral Melatonin When Combined with Thoracic Epidural Analgesia in Patients with Bilateral Multiple Fracture Ribs

Figures & data

Figure 1 Flow chart.

Table 1 Demographic Data in Both Groups

Variables		Placebo Group	Melatonin Group	P value
Age (y)		25.23 ± 1.17	25.15 ± 1.15	0.776
BMI (kg/m^2)		25.4 ± 1.11	25.38 ± 1.13	0.921
Sex	Male	32 (80%)	33 (82.5%)	0.775
	Female	8 (20%)	7 (17.5%)
ASA	ASA I	22 (55%)	19 (47.5%)	0.655
	ASA II	18 (45%)	21 (52.5%)
Fracture ribs	3 ribs	33 (82.5%)	32 (80%)	0.775
	4 ribs	7 (17.5%)	8 (20%)

Table 2 Arterial Oxygen Saturation (SpO₂), Arterial Oxygen Tension (PaO₂), Arterial Carbon Dioxide Concentration (PaCO₂) During First 24 Hours After Start Bupivacaine Infusion in Thoracic Epidural Catheter

	SpO2			PaO2			PaCO2
	Placebo Group	Melatonin Group	P value	Placebo Group	Melatonin Group	P value	Placebo Group	Melatonin Group	P value
	Mean ± SD	Mean ± SD		Mean ± SD	Mean ± SD		Mean ± SD	Mean ± SD
Before	86.4 ± 2.5	86.6 ± 2.3	0.642	57.22 ± 4.56	58.50 ± 4.30	0.203	24.70 ± 2.57	24.80 ± 1.99	0.848
1 H	95.4 ± 2.5	94.6 ± 2.3	0.165	75.88 ± 10.88	75.90 ± 10.0	0.993	28.68 ± 2.94	27.80 ± 1.99	0.128
6 H	94.2 ± 2.7	93.6 ± 2.3	0.291	79.90 ± 11.42	79.63 ± 11.37	0.914	32.63 ± 3.36	31.80 ± 2.43	0.218
12 H	95.2 ± 2.7	94.7 ± 2.4	0.392	84.34 ± 11.20	80.63 ± 10.32	0.129	32.63 ± 3.36	33.75 ± 2.58	0.101
18 H	96.1 ± 2.8	95.7 ± 2.4	0.392	89.63 ± 12.64	88.00 ± 10.14	0.529	34.58 ± 3.67	33.95 ± 2.25	0.101
24 H	99.1 ± 2.8	99.9 ± 2.6	0.223	105.78 ± 22.43	112.15 ± 21.1	0.198	34.58 ± 3.67	33.95 ± 2.25	0.367

Figure 2 The visual analog score in both groups: in the first 24 hours postoperative.

Figure 3 The visual analog score in both groups (2–5 days) postoperative.

Table 3 Demographic Data, Total Rescue Analgesia Consumption, Mean Infusion Rate of, and Duration of Bupivacaine Infusion

Variables	Placebo Group	Melatonin Group	P value
Mean infusion rate of analgesic bupivacaine controlling the pain (mL/kg/hour)	0.17 ± 0.014	0.12 ± 0.001	<0.001
Duration of infusion (h)	100.05 ± 3.39	96.48 ± 1.87	<0.001
Total rescue morphine consumption (mg)	31.8 ± 1.41	13.03 ± 0.85	<0.001

Table 4 Complication in Both Groups

Complications	Placebo Group	Melatonin Group	P value
Drowsiness and dizziness	0	1 (2.5%)	1
Hypotension	0	0	–
Bradycardia	1 (2.5%)	1 (2.5%)	1.54
Dry mouth	0	1 (2.5%)	1
Nausea/vomiting	6 (15%)	21 (52.5%)	0.0001

Table 5 The Quality of Sleep of the Patients Assessed by Consensus Sleep Diary in Both Groups

Quality of the sleep		Placebo Group					Melatonin Group
		Very poor	Poor	Fair	Good	Very good	Very poor	Poor	Fair	Good	Very good
Number and Percentage of patients	1st night 2nd night 3rd night	5 (12.5) 2 (5) 0	15 (12.5) 5(12.5) 0	15 (12.5) 23 (57.5) 31 (77.5)	5 (12.5) 9 (22.5) 5 (12.5)	0 1(2.5) 4 (10)	0 0 0	0 0 0	20(50) 13(32.5) 7(17.5)	19(47.5) 7(17.5) 5(12.5)	1(2.5) 20 (50) 28(70%)

Note: Data were presented as percentage (%) and number.