Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy, a double-blind, placebo-controlled trial

Peer review under responsibility of Egyptian Society of Anesthesiologists.

Figures & data

able 1 Ramsay sedation score.

Score	Observation
1	Anxious, agitated or restless
2	Cooperative, oriented and tranquil
3	Responsive to commands
4	Asleep, but with brisk response to light glabellar tap or loud auditory stimulus
5	Asleep, sluggish response to glabellar tap or auditory stimulus
6	Asleep, no response

igure 1 A 7-point Likert-like verbal rating scale for assessment of patients’ and surgeons‘ satisfaction.

able 2 Intraoperative bleeding score classification.

Score	Descriptions
0	No bleeding
I	Slight bleeding, no suctioning of blood required
II	Slight bleeding, occasional required suctioning. Surgical field not threatened
III	Slight bleeding, frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed
IV	Moderate bleeding, frequent suctioning required. Bleeding threatens surgical field directly after suction is removed
V	Severe bleeding, constant suctioning required. Bleeding rate is faster than its removal by suctioning as surgical field is severely threatened and surgery becomes impossible

igure 2 Flowchart of patients (study design).

able 3 The demographic data.

Variables	C group (n = 25)	TDF group (n = 25)	TDM group (n = 25)	p-value
Age (yr.)	43.56 ± 5.7	42.6 ± 4.62	44.56 ± 3.4	0.83
Sex (M/F)	15/10	14/11	13/12	0.21
Weight (kg)	77.18 ± 4.2	76.32 ± 5.9	78.4 ± 3.1	0.57
Height (cm)	166.56 ± 5. 4	170.71 ± 4	168.6 ± 5.2	0.2
ASA (I/II)	11/14	9/16	7/18	0.85
Duration of anesthesia (min)	112.5 ± 6.5	112.8 ± 6.8	111.7 ± 5.2	0.51

Data are presented as mean ± SD. ASA: American Society of Anesthesiologists.

P > 0.05 was considered statistically non-significant between the 3 groups.

igure 3 The heart rate changes (beats/min). Lines are mean heart rate and error bars are SD.

igure 4 The mean arterial blood pressure (mmHg).

igure 5 Sedation score (Ramsay sedation score).

igure 6 Visual analog scale (VAS).

able 4 Postoperative data.

Postoperative data	C group (n = 25)	TDF group (n = 25)	TDM group (n = 25)	p-value
Time for 1st rescue analgesic (minutes) postop.	29 .8 ± 2.71^†	231.5 ± 5. 81	212.5 ± 3.3	<0.001^⁎
Total pethidine requirements (mg) 12 h postop.	120.8 ± 7.54^†	56.32 ± 6.8	60.92 ± 6.4	<0.001^⁎
Serum cortisol 2 h postop. (μg/dl).	31.36 ± 4.64^†	21.34 ± 3.3	21.2 ± 3.9	<0.001^⁎
Patient‘s satisfaction score	2 (2–2.5)^†	6 (5–6)	6 (5–6)	<0.001^⁎
Intraoperative bleeding (0–2)	15(60%)	17(68%)	20(80%)^‡	<0.001^⁎
Surgeon‘s satisfaction score	4 (4–5)	4 (4–5)	7 (6–7)^‡	<0.001^⁎

Data are presented as mean (SD) or median (interquartile range). ^∗ Denotes significant difference.

#x204E; P < 0.001 is considered statistically significant between the 3 groups.

#x2020; P < 0.001 was considered statistically significant between groups II and III and group I.

#x2021; P < 0.001 was considered statistically significant between groups I and II and group III.