Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202210634713270 Date of Approval: 19/10/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ketamine infiltration decreases opioid requirement after thyroid surgery
Official scientific title Ketamine infiltration decreases opioid requirement after thyroid surgery
Brief summary describing the background and objectives of the trial Postoperative pain increases the risk of postoperative complications and may predispose to chronic postsurgical pain. This study aims to evaluate the impact of ketamine wound infiltration versus placebo at the end of thyroid surgery on postoperative pain and analgesic requirements.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 04/11/2018
Actual trial start date 04/11/2018
Anticipated date of last follow up 01/03/2019
Actual Last follow-up date 01/03/2019
Anticipated target sample size (number of participants) 62
Actual target sample size (number of participants) 62
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group K Group K represents wound infiltration using 10 ml of a solution containing 2m kg-1 of ketamine 6 months In this randomized controlled trial, we prospectively studied patients who underwent thyroid surgery. Patients were randomized into two groups: group S, local infiltration was performed using 10 ml of a physiological saline solution; group K, 10 ml of a solution containing 2 mg / kg ketamine was infiltrated. Standardized thyroidectomies were performed in the 2 groups. Pain perception was measured using a visual analog scale (VAS) every 10 minutes in the post-anesthetic care unit (PACU) for 2 hours and every 6 hours during the first 24 hours. The opioids requirement in the PACU was evaluated. Comparison between the 2 groups was carried out. 31
Control Group Group S group S, local infiltration was performed using 10 ml of a physiological saline solution 6 months In this randomized controlled trial, we prospectively studied patients who underwent thyroid surgery. Patients were randomized into two groups: group S, local infiltration was performed using 10 ml of a physiological saline solution; group K, 10 ml of a solution containing 2 mg / kg ketamine was infiltrated. Standardized thyroidectomies were performed in the 2 groups. Pain perception was measured using a visual analog scale (VAS) every 10 minutes in the post-anesthetic care unit (PACU) for 2 hours and every 6 hours during the first 24 hours. The opioids requirement in the PACU was evaluated. Comparison between the 2 groups was carried out. 31 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged 18 to 65 who scheduled thyroid surgery were included in this study if they had an ASA score (American Society of Anesthesiology) of I or II. Patients with unstable diabetes, an allergy to study drugs, a history of previous cervical surgery, or a history of cardiac or respiratory disease, as well as patients on long-term analgesic or corticosteroids, were not included in this study. Patients who had major complications, such as allergic reactions to anesthetic drugs and major bleeding Patients whose surgery duration exceeded 3 hours were excluded from this study. Patients who underwent a neck dissection associated with thyroid surgery 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/10/2018 Comite de protection des personne du Sud
Ethics Committee Address
Street address City Postal code Country
ISIS. EL AIN ROAD KM 0.5. IN FRONT OF THE MEDICAL SCHOOL OF SFAX Sfax 3000 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcomes were to determine the intensity of the pain using VAS in 0-100 in the first 24 hours. The VAS score was assessed every 10 minutes in the PACU for 2 hours and every 6 hours during the first 24 hours after the operation in the ENT department
Secondary Outcome Opioid requirements were recorded during the PACU admission period. The occurrence of side effects of opioid and ketamine was noted. During the PACU admission period: 2 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Habib Bourguiba University Hospital El Ain Street Km 0.5 Sfax 3029 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Habib Bourguiba University Hospital El Ain Road Km 0.5 Sfax 3000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Habib Bourguiba University Hospital El Ain Road Km0.5 Sfax 3000 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Imen Zouche Department of anesthesiology. Habib Bourguiba University Hospital. EL Ain Road km 0.5 Sfax 3000 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moncef Sellami sellami_moncef@yahoo.fr 0021624050980 Habib Bourguiba University Hospital. El AIn Road Km 0.5
City Postal code Country Position/Affiliation
Sfax 3000 Tunisia Department of otorhinolaryngology
Role Name Email Phone Street address
Public Enquiries Maroua Bouhali safa123bouhali@gmail.com 0021696737320 Habib Bourguiba University Hospital. El AIn Road Km 0.5
City Postal code Country Position/Affiliation
Sfax 3000 Tunisia Department of anesthesiology
Role Name Email Phone Street address
Scientific Enquiries Imen Zouche imen.zouche2016@gmail.com 0021658127457 Habib Bourguiba University Hospital. El AIn Road Km 0.5
City Postal code Country Position/Affiliation
Sfax 3000 Tunisia Department of anesthesiology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study protocol, Statistical Analysis Plan, Analytic Code will be available beginning 3 months and ending 5 years following article publication Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Proposal should be directed to sellami_moncef@medecinesfax.org To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 10/10/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 10/10/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information