Pediatric bowel preparation: Sodium picosulfate, magnesium oxide, citric acid vs polyethylene glycol, a randomized trial

Table 1 Demographic and baseline characteristics, intent-to-treat population

	9-12 yr old			13-16 yr old		All SPMC 1 dose × 2 (n = 32)	All PEG (n = 30)
n (%)	SPMC ½ dose × 2 (n = 16)	SPMC 1 dose × 2 (n = 16)	PEG (n = 16)	SPMC 1 dose × 2 (n = 16)	PEG (n = 14)
Age (yr), mean (SD)	10.8 (1.0)	10.5 (1.2)	10.4 (1.2)	15.0 (1.0)	14.9 (0.9)	12.8 (2.5)	12.5 (2.5)
Female, n (%)	11 (68.8)	12 (75.0)	8 (50.0)	11 (68.8)	11 (78.6)	23 (71.9)	19 (63.3)
White race, n (%)	15 (93.8)	16 (100)	11 (68.8)	15 (93.8)	14 (100)	31 (96.9)	25 (83.3)
BMI (kg/m2), mean (SD)	19.0 (4.8)	20.4 (5.3)	19.4 (5.2)	24.9 (7.0)	23.1 (6.5)	22.6 (6.5)	21.1 (6.0)

BMI: Body mass index; ITT: Intent-to-treat; PEG: Polyethylene glycol; SD: Standard deviation; SPMC: Sodium picosulfate, magnesium oxide, and citric acid.

Table 2 Summary of adverse events, safety population

	9-12 yr old			13-16 yr old		All SPMC 1 dose × 2 (n = 33)	All PEG (n = 27)
n (%)	SPMC ½ dose × 2 (n = 15)	SPMC 1 dose × 2 (n = 17)	PEG (n = 15)	SPMC 1 dose × 2 (n = 16)	PEG (n = 12)
Any TEAE	8 (53.3)	5 (29.4)	6 (40.0)	10 (62.5)	11 (91.7)	15 (45.5)	17 (63.0)
Deaths	0	0	0	0	0	0	0
Serious TEAE	0	0	0	0	0	0	0
TEAE leading to study discontinuation	0	0	0	0	0	0	0
Severe AE	0	0	0	1 (6.3)	0	1 (3.0)	0
ADR	1 (6.7)	0	1 (6.7)	4 (25.0)	4 (33.3)	4 (12.1)	5 (18.5)
Nausea	1 (6.7)	0	1 (6.7)	1 (6.3)	3 (25.0)	1 (3.0)	4 (14.8)
Vomiting	1 (6.7)	0	0	2 (12.5)	1 (8.3)	2 (6.1)	1 (3.7)
Abdominal pain	0	0	0	1 (6.3)	0	1 (3.0)	0
Retching	0	0	0	1 (6.3)	0	1 (3.0)	0
Migraine	1 (6.7)	0	0	0	0	0	0
Hyperhidrosis	0	0	0	1 (6.3)	0	1 (3.0)	0
Serious ADR	0	0	0	0	0	0	0

SPMC: Sodium picosulfate, magnesium oxide, and citric acid; PEG: Polyethylene glycol; ADR: Adverse drug reaction; AE: Adverse event; PEG: Polyethylene glycol; SPMC: Sodium picosulfate, magnesium oxide, and citric acid; TEAE: Treatment-emergent adverse event.