A randomized, placebo controlled, trial of preoperative sustained release betamethasone plus non-controlled intraoperative ketorolac or fentanyl on pain after diagnostic laparoscopy or laparoscopic tubal ligation

ISRCTN	ISRCTN52633712
DOI	https://doi.org/10.1186/ISRCTN52633712
Secondary identifying numbers	Betamethasone ARF#1212

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Roger Carroll
Scientific

UT Graduate School of Medicine
Department of Anesthesiology
1924 Alcoa Highway
Knoxville
37920
United States of America

Phone	+1 865 544 9469
Email	rccarrol@mc.utmck.edu

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Postoperative pain
Intervention	Sustained release betamethasone versus placebo.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Betamethasone, ketorolac, fentanyl
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2002
Completion date	31/12/2002

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	74
Key inclusion criteria	Patients undergoing laparoscopic surgery at University of Tennessee Medical Centre Knoxville, Tennessee (USA)
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2002
Date of final enrolment	31/12/2002

UT Graduate School of Medicine

Knoxville
37920
United States of America

University of Tennessee Anesthesiology Research Fund (USA)
University/education

University of Tennessee Graduate School of Medicine
Department of Anesthesiology
1924 Alcoa Highway
Knoxville
37920
United States of America

Research organisation

University of Tennessee Anesthesiology Research Fund (USA)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	21/08/2003		Yes	No