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[2010-019787-36] Oral Ondansetron versus Domperidone for Acute Gastroenteritis in Pediatric Emergency Departments: Multicenter Double Blind Randomized Controlled Trial.

Marchetti F, Bonati M, Maestro A, Zanon D, Rovere F, Arrighini A, et al.

Source : PLOS ONE | https://doi.org/10.1371/journal.pone.0165441

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Summary

1. Study profile

1.1. Flowchart

2. Results

2.1. Baseline Characteristics of the Study Patients

2.2. Outcome measures during Emergency Department stay

2.3. Outcome measures at telephone follow up

Methods

Objective:

Aim of the study is to evaluate whether a single oral dose of ondansetron vs domperidone or placebo improves outcomes in children with gastroenteritis.

Assessment:

A prospective, multicenter, double-blind randomized controlled trial involved children admitted to 15 pediatric emergency departments (EDs) in Italy was performed between July 7, 2011 (first randomization) and November 3, 2013 (last follow-up).
In this study, 356 children were randomized to receive one oral dose of ondansetron (0.15 mg/kg) or domperidone (0.5 mg/kg) or placebo.

The primary outcome is the percentage of children receiving nasogastric or intravenous rehydration after symptomatic oral treatment failure, defined as vomiting or fluid refusal after the second ORT attempt.

Secondary outcomes are:
– The percentage of subjects remaining in ED for observation stay for more than 6 hours;
– The percentage of subjects requiring hospital admission during the ED stay;
– Subjects with episodes of vomiting and number of episodes in the 3 treatment groups during the ED stay and during the 48-hour follow-up period;
– The rate of success at the second ORT attempt and the percentage of subjects requiring laboratory tests during ED stay;
– Subjects with episodes of diarrhea and the number of episodes in the 3 treatment groups were evaluated both during ED stay and during the 48-hour follow-up period;
– The percentage of subjects presenting adverse events during ED stay and during the 48-hour follow-up period.

Study principles:

As the analysis is the second and final interim analysis of the study, the level of significance was set at 0.014 and the confidence intervals are 98.6%.

Qualitative variables are described with frequencies and level percentages (Column percentages here).
Quantitative variables are described with means and standard deviations, quartiles.

The analyzes were carried out using logistic regressions.

1. Study profile

1.1. Flowchart

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Flowchart

A total of 356 children were randomly assigned to the study groups: 119 to domperidone, 119 to ondansetron and 118 to placebo.

Figure 1 : Study profile – Flowchart – Flowchart

2. Results

2.1. Baseline Characteristics of the Study Patients

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The basic characteristics of the children are similar between the randomization groups.

		Population		Group ITT (V3)
		_		domperidone		ondansetron		placebo
		N=356		N=119		N=119		N=118
		Mean±SD Med(Q1Q3) or		Mean±SD Med(Q1Q3) or		Mean±SD Med(Q1Q3) or		Mean±SD Med(Q1Q3) or
Variable		n	%col	n	%col	n	%col	n	%col
Age (years) (V7)	Mean ±SD	3.35	±1.52	3.36	±1.62	3.21	±1.4	3.49	±1.54
	Median (Q1-Q3)	3.2	(2-4.5)	3.2	(1.9-4.6)	3.1	(2.1-4.2)	3.25	(2.1-4.7)

Sex (V8)	Female	180	50.6	54	45.4	62	52.1	64	54.2
	Male	176	49.4	65	54.6	57	47.9	54	45.8
	Total	356	100	119	33.4	119	33.4	118	33.1

Child weight (kg) (V9)	Mean ±SD	15.28	±4.06	15.06	±4.21	15.1	±4.05	15.69	±3.93
	Median (Q1-Q3)	14.9	(12-18)	14.5	(11.7-17.5)	14.2	(11.5-18.2)	15.5	(12.7-18.3)

Child height (cm) (V10)	Mean ±SD	99.48	±15.39	98.09	±13.41	99.44	±13.89	100.93	±18.39
	Median (Q1-Q3)	99	(88-110)	99	(87-110)	98.5	(89-110)	99	(89-110)

Duration of vomiting before enrollment (hours) (V11)	Mean ±SD	18.9	±20.75	15.71	±17.42	20.97	±23.02	20.05	±21.2
	Median (Q1-Q3)	10	(6-24)	9	(5-18)	10	(6-24)	12	(7-20)

Number of episodes of vomiting in the last 24 hours (V12)	Mean ±SD	8.47	±4.38	8.37	±3.94	8.37	±4.46	8.69	±4.74
	Median (Q1-Q3)	8	(5.25-10)	8	(6-10)	7	(5-10)	8	(6-10)

Number of episodes of vomiting in the last 6 hours (V13)	Mean ±SD	5.68	±3.53	5.92	±3.31	5.65	±3.77	5.46	±3.52
	Median (Q1-Q3)	5	(3-7)	6	(4-7)	5	(3-7)	5	(3-7)

Presence of diarrhea (V14)	Yes	147	41.3	47	39.5	51	42.9	49	41.5
	No	209	58.7	72	60.5	68	57.1	69	58.5
	Total	356	100	119	33.4	119	33.4	118	33.1

Drugs taken at home (V15)	Yes	57	16	21	17.6	19	16	17	14.4
	No	299	84	98	82.4	100	84	100	85.6
	Total	356	100	119	33.4	119	33.4	118	33.1

Dehydration score (V16)	Mean ±SD	8	±1.58	7.94	±1.62	8.02	±1.52	8.03	±1.62
	Median (Q1-Q3)	8	(7-9)	8	(7-9)	8	(7-9)	8	(7-9)

Table 1 : Results – Baseline Characteristics of the Study Patients – Cross sort

# Child height (cm) (V10) : 79 unavailable data, 25 individuals whose the “Group ITT (V3)” item is filled “domperidone”, 29 individuals whose the “Group ITT (V3)” item is filled “ondansetron” and 25 individuals whose the “Group ITT (V3)” item is filled “placebo”

2.2. Outcome measures during Emergency Department stay

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Based on analysis, ondansetron significantly reduces the number of:

– Subjects receiving nasogastric or intravenous rehydration both vs domperidone (OR 0.396, 98.6% CI 0.166 to 0.945) and placebo (OR 0.33, 98.6% CI 0.284 to 0.383);
– Subjects needing observation stay for more than 6 hours for the same illness both vs domperidone (OR 0.448, 98.6% CI 0.206 to 0.971) and placebo (OR 0.4, 98.6% CI 0.373 to 0.448);
– Subjects with episodes of vomiting during ED stay both vs domperidone (OR 0.252, 98.6% CI 0.118 to 0.535) and placebo (OR 0.285, 98.6% CI 0.254 to 0.317);
– Episodes of vomiting during ED stay vs placebo (OR 0.5, 98.6% CI 0.298 to 0.84);
– Subjects without success at second ORT attempt both vs domperidone (OR 0.213, 98.6% CI 0.088 to 0.517) and placebo (OR 0.203, 98.6% CI 0.164 to 0.252);
– Subjects requiring laboratory tests vs placebo (OR 0.351, 98.6% CI 0.314 to 0.394).

		Population		Group ITT (V3)
		_		domperidone		ondansetron		placebo
		N=356		N=119		N=119		N=118
		Mean±SD Med(Q1Q3) or		Mean±SD Med(Q1Q3) or		Mean±SD Med(Q1Q3) or		Mean±SD Med(Q1Q3) or
Variable		n	%col	n	%col	n	%col	n	%col
Requiring intravenous rehydration (V17)	Yes	78	21.9	30	25.2	14	11.8	34	28.8
	No	278	78.1	89	74.8	105	88.2	84	71.2
	Total	356	100	119	33.4	119	33.4	118	33.1

Observation stay in ED >6 hours (V18)	Yes	96	27	37	31.1	20	16.8	39	33.1
	No	260	73	82	68.9	99	83.2	79	66.9
	Total	356	100	119	33.4	119	33.4	118	33.1

Requiring hospital admission (V19)	Yes	46	12.9	16	13.4	10	8.4	20	16.9
	No	310	87.1	103	86.6	109	91.6	98	83.1
	Total	356	100	119	33.4	119	33.4	118	33.1

Presence of vomiting during ED stay (V20)	Yes	122	34.3	53	44.5	20	16.8	49	41.5
	No	234	65.7	66	55.5	99	83.2	69	58.5
	Total	356	100	119	33.4	119	33.4	118	33.1

Number of episodes of vomiting during ED stay (V21) N=122	Mean ±SD	2.13	±1.7	2.23	±1.8	1.4	±0.68	2.33	±1.82
	Median (Q1-Q3)	2	(1-3)	2	(1-3)	1	(1-2)	2	(1-3)

Success at second ORT attempt (V22)	Yes	261	73.3	78	65.5	107	89.9	76	64.4
	No	95	26.7	41	34.5	12	10.1	42	35.6
	Total	356	100	119	33.4	119	33.4	118	33.1

Requiring laboratory tests (V23)	Yes	85	24.1	31	26.1	17	14.3	37	32.2
	No	268	75.9	88	73.9	102	85.7	78	67.8
	Total	353	100	119	33.7	119	33.7	115	32.6

Presence of diarrhea during ED stay (V24)	Yes	79	22.2	26	21.8	33	27.7	20	16.9
	No	277	77.8	93	78.2	86	72.3	98	83.1
	Total	356	100	119	33.4	119	33.4	118	33.1

Number of episodes of diarrhea during ED stay (V25) N=79	Mean ±SD	2.42	±2.22	1.88	±1.88	3.09	±2.45	2	±2.03
	Median (Q1-Q3)	2	(1-2)	1	(1-2)	2	(2-4)	1.5	(1-2)

Table 2 : Results – Outcome measures during Emergency Department stay – Cross sort

# Requiring laboratory tests (V23) : 3 unavailable data, 3 individuals whose the “Group ITT (V3)” item is filled “placebo”

		Group ITT (V3)
		ondansetron	placebo
		N=119	N=118
Variable		OR*[98.6%CI]	OR*[98.6%CI]
Requiring intravenous rehydration (V17)	Yes	0.396[0.166 ; 0.945]	1.201[0.584 ; 2.467]
	No	– Ref – domperidone	– Ref – domperidone

Observation stay in ED >6 hours (V18)	Yes	0.448[0.206 ; 0.971]	1.094[0.552 ; 2.169]
	No	– Ref – domperidone	– Ref – domperidone

Requiring hospital admission (V19)	Yes	0.591[0.207 ; 1.682]	1.314[0.537 ; 3.213]
	No	– Ref – domperidone	– Ref – domperidone

Presence of vomiting during ED stay (V20)	Yes	0.252[0.118 ; 0.535]	0.884[0.464 ; 1.686]
	No	– Ref – domperidone	– Ref – domperidone

Number of episodes of vomiting during ED stay (V21) N=122		Ref – domperidone 0.516[0.234 ; 1.138]	Ref – domperidone 1.032[0.785 ; 1.355]

Success at second ORT attempt (V22)	Yes	– Ref – domperidone	– Ref – domperidone
	No	0.213[0.088 ; 0.517]	1.051[0.538 ; 2.053]

Requiring laboratory tests (V23)	Yes	0.473[0.208 ; 1.078]	1.347[0.662 ; 2.739]
	No	– Ref – domperidone	– Ref – domperidone

Presence of diarrhea during ED stay (V24)	Yes	1.372[0.654 ; 2.882]	0.730[0.324 ; 1.645]
	No	– Ref – domperidone	– Ref – domperidone

Number of episodes of diarrhea during ED stay (V25) N=79		Ref – domperidone 1.332[0.899 ; 1.974]	Ref – domperidone 1.053[0.647 ; 1.713]

*OR : Odds Ratio

Table 3 : Results – Outcome measures during Emergency Department stay – Association strengths

2.3. Outcome measures at telephone follow up

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No statistically significant differences are seen among the three groups for subjects readmitted in ED for the same illness, subjects with episodes of vomiting and diarrhea in the 48 hours follow-up and number of episode of vomiting and diarrhea in the last 24 hours of follow-up.

		Population		Group ITT (V3)
		_		domperidone		ondansetron		placebo
		N=356		N=119		N=119		N=118
		Mean±SD Med(Q1Q3) or		Mean±SD Med(Q1Q3) or		Mean±SD Med(Q1Q3) or		Mean±SD Med(Q1Q3) or
Variable		n	%col	n	%col	n	%col	n	%col
Readmitted to ED after discharge (V27)	Yes	36	10.2	12	10.1	11	9.3	13	11.1
	No	318	89.8	107	89.9	107	90.7	104	88.9
	Total	354	100	119	33.6	118	33.3	117	33.1

Episodes of vomiting during 48 h f-up (V28)	Yes	104	29.4	27	22.7	36	30.5	41	35
	No	250	70.6	92	77.3	82	69.5	76	65
	Total	354	100	119	33.6	118	33.3	117	33.1

Number of episodes of vomiting in the last 24 hours of f-up (V29) N=104	Mean ±SD	2.38	±1.91	2.54	±2.08	2.25	±1.71	2.37	±1.97
	Median (Q1-Q3)	2	(1-3)	2	(1-3)	1	(1-3)	1.5	(1-3)

Episodes of diarrhea during 48 h f-up (V30)	Yes	144	40.7	51	42.9	49	41.5	44	37.6
	No	210	59.3	68	57.1	69	58.5	73	62.4
	Total	354	100	119	33.6	118	33.3	117	33.1

Number of episodes of diarrhea in the last 24 hours of f-up (V31) N=144	Mean ±SD	4.44	±6.3	3.93	±3.95	4.82	±7.77	4.66	±6.93
	Median (Q1-Q3)	3	(2-4)	3	(2-4)	3	(2-4)	3	(1-5)

Table 4 : Results – Outcome measures at telephone follow up – Cross sort

# Readmitted to ED after discharge (V27) : 2 unavailable data, 1 individual whose the “Group ITT (V3)” item is filled “ondansetron” and 1 individual whose the “Group ITT (V3)” item is filled “placebo”

# Episodes of vomiting during 48 h f-up (V28) : 2 unavailable data, 1 individual whose the “Group ITT (V3)” item is filled “ondansetron” and 1 individual whose the “Group ITT (V3)” item is filled “placebo”

# Number of episodes of vomiting in the last 24 hours of f-up (V29) : 13 unavailable data, 6 individuals whose the “Group ITT (V3)” item is filled “ondansetron” and 7 individuals whose the “Group ITT (V3)” item is filled “placebo”

# Episodes of diarrhea during 48 h f-up (V30) : 2 unavailable data, 1 individual whose the “Group ITT (V3)” item is filled “ondansetron” and 1 individual whose the “Group ITT (V3)” item is filled “placebo”

# Number of episodes of diarrhea in the last 24 hours of f-up (V31) : 6 unavailable data, 3 individuals whose the “Group ITT (V3)” item is filled “ondansetron” and 3 individuals whose the “Group ITT (V3)” item is filled “placebo”

		Group ITT (V3)
		ondansetron	placebo
		N=119	N=118
Variable		OR*[98.6%CI]	OR*[98.6%CI]
Readmitted to ED after discharge (V27)	Yes	0.917[0.312 ; 2.697]	1.115[0.394 ; 3.154]
	No	– Ref – domperidone	– Ref – domperidone

Episodes of vomiting during 48 h f-up (V28)	Yes	1.496[0.722 ; 3.099]	1.838[0.896 ; 3.770]
	No	– Ref – domperidone	– Ref – domperidone

Number of episodes of vomiting in the last 24 hours of f-up (V29) N=104		Ref – domperidone 0.923[0.653 ; 1.305]	Ref – domperidone 0.957[0.692 ; 1.322]

Episodes of diarrhea during 48 h f-up (V30)	Yes	0.947[0.496 ; 1.807]	0.804[0.418 ; 1.545]
	No	– Ref – domperidone	– Ref – domperidone

Number of episodes of diarrhea in the last 24 hours of f-up (V31) N=144		Ref – domperidone 1.025[0.940 ; 1.119]	Ref – domperidone 1.022[0.933 ; 1.119]

*OR : Odds Ratio

Table 5 : Results – Outcome measures at telephone follow up – Association strengths

Tables and figures

Table 1 : Results – Baseline Characteristics of the Study Patients – Cross sort

Table 2 : Results – Outcome measures during Emergency Department stay – Cross sort

Table 3 : Results – Outcome measures during Emergency Department stay – Association strengths

Table 4 : Results – Outcome measures at telephone follow up – Cross sort

Table 5 : Results – Outcome measures at telephone follow up – Association strengths

Figure 1 : Study profile – Flowchart – Flowchart

Date of completion : 13 April 2021

Implementer : RUS

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Oral Ondansetron versus Domperidone for Acute Gastroenteritis in Pediatric Emergency Departments: Multicenter Double Blind Randomized Controlled Trial

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