Clinical Trials Register

Summary
EudraCT Number:	2017-001014-28
Sponsor's Protocol Code Number:	studioTRAPPED
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-06-08
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2017-001014-28

A.3

Full title of the trial

Effects of a reduced dose of tramadol intravenous, in association with paracetamol, in control of Postoperative Pain after tonsillectomy or adenotonsillectomy in Paediatric population:a clinical, controlled, randomized, single-blind study (TRAPPED study)

Effetti di una ridotta dose di TRAmadolo endovenoso, in associazione al trattamento con paracetamolo, nel controllo del dolore Postoperatorio, dopo intervento di tonsillectomia o adenotonsillectomia in popolazione PEDiatrica: studio clinico, controllato, randomizzato, singolo cieco. (studio TRAPPED)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.3.2

Name or abbreviated title of the trial where available

TRAPPED study

studio TRAPPED

A.4.1

Sponsor's protocol code number

studioTRAPPED

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AZIENDA PROVINCIALE PER I SERVIZI SANITARI - PROVINCIA AUTONOMA DI TRENTO
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	nessu finanziamento
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	APSS- Ospedale S. Chiara
B.5.2	Functional name of contact point	U.O. Anestesia e Rianimazione 1 del
B.5.3	Address:
B.5.3.1	Street Address	Largo Medaglie d'oro, 9
B.5.3.2	Town/ city	Trento
B.5.3.3	Post code	38122
B.5.3.4	Country	Italy
B.5.4	Telephone number	0461903298
B.5.5	Fax number	0461903355
B.5.6	E-mail	massimiliano.detassis@apss.tn.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	CONTRAMAL - 100 MG/2 ML SOLUZIONE INIETTABILE 5 FIALE 2 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	GRUNENTHAL ITALIA S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRAMADOLO CLORIDRATO
D.3.9.1	CAS number	36282-47-0
D.3.9.2	Current sponsor code	n.a.
D.3.9.3	Other descriptive name	Tramadol Hydrochloride
D.3.9.4	EV Substance Code	252-950-2
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	PARACETAMOLO S.A.L.F. - 10 MG/ML SOLUZIONE PER INFUSIONE 25 FLACONI IN VETRO DA 100 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	S.A.L.F. SPA LABORATORIO FARMACOLOGICO
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PARACETAMOLO
D.3.9.1	CAS number	103-90-2
D.3.9.2	Current sponsor code	n.a.
D.3.9.4	EV Substance Code	numero EINECS 2
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

tonsillectomy or adenotonsillectomy

intervento di tonsillectomia o adenotonsillectomia

E.1.1.1

Medical condition in easily understood language

tonsillectomy or adenotonsillectomy

intervento di tonsillectomia o adenotonsillectomia

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10001256
E.1.2	Term	Adenotonsillectomy
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10044006
E.1.2	Term	Tonsillectomy
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the effect of the administration of a low dose of tramadol (1mg / kg) in combination with Paracetamol and the onset of side effects in the first 12 hours after surgery

Valutare l¿effetto della somministrazione di una bassa dose di tramadolo (1mg/kg), durante l¿intervento chirurgico, nel controllo del dolore post operatorio e nella comparsa di effetti collaterali nelle prime 12 ore in associazione ad un regime di trattamento basato sulla somministrazione oraria di paracetamolo.

E.2.2

Secondary objectives of the trial

Determine the number of patients with postoperative nausea and vomiting within 12 hours of surgery, and the average VAS value (Wong-Baker scale) at 6 hours after surgery.

stabilire il numero di pazienti con nausea e vomito postoperatori entro le 12 ore dall¿intervento chirurgico., ed il valore di VAS medio (scala di Wong-Baker) alle 6 ore dall¿intervento chirurgico.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

patients selected for tonsillectomy or adenotonsillectomy
age between 4 - 10,
ASA's classification: 1 - 2

Criteri di eleggibilità sono l’età compresa tra 4 e 10 anni, selezionati per intervento in elezione di tonsillectomia oppure adenotonsillectomia. Verranno arruolati nello studio soltanto pazienti con classificazione ASA 1 e 2.

E.4

Principal exclusion criteria

ASA's classification = > 3
Patients <4 years of age and patients over 10 years
patients rundergoing emergency tonsillectomy
or adenotonsillectomy

Verranno esclusi pazienti con valutazione ASA 3 o superiori e pazienti sottoposti a intervento di revisione di tonsillectomia in regime di urgenza.
Verranno esclusi i pazienti con età < 4 anni e i pazienti con età >10 anni.

E.5 End points

E.5.1

Primary end point(s)

verificare l’effetto del tramadolo a basse dosi nel controllo del dolore post operatorio nelle prime 12 ore, rispetto al gruppo controllo, analizzando il numero e la percentuale di soggetti con VAS>4 (scala di Wong-Baker) nel gruppo sperimentale rispetto al gruppo controllo, entro le 12 ore dall’intervento chirurgico.

E.5.1.1

Timepoint(s) of evaluation of this end point

entro le 12 ore dall’intervento chirurgico.

E.5.2

Secondary end point(s)

stabilire il numero di pazienti con nausea e vomito postoperatori. Pertanto si vuole valutare il numero e la percentuale di pazienti che presentano effetti collaterali (nausea e/o vomito) nel gruppo sperimentale rispetto al gruppo controllo entro le 12 ore dall¿intervento chirurgico
; valore di VAS medio (scala di Wong-Baker) nel gruppo sperimentale e nel gruppo controllo alle 6 ore dall¿intervento chirurgico.

E.5.2.1

Timepoint(s) of evaluation of this end point

entro le 12 ore dall¿intervento chirurgico; alle 6 ore dall¿intervento chirurgico.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Not applicable

n.a.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-10-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-05-25

P. End of Trial
P.	End of Trial Status	Completed

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials