Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:18 AM
Study NCT ID:
NCT07378904
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-30
First Post:
2026-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sterile Water Injection vs Morphine for Renal Colic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056844', 'term': 'Renal Colic'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned in a 1:1:1 ratio to one of three groups: single intradermal sterile water injection (ISWI), four ISWI injections, or intravenous morphine. Each participant will receive only the assigned intervention, and outcomes (pain reduction, analgesic use, patient satisfaction) will be compared between groups. The study is conducted in a double-blind manner, meaning the emergency physician assessing pain and the epidemiologist performing data analysis are blinded to treatment allocation, while patients are aware of the treatment they receive.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-22', 'studyFirstSubmitDate': '2026-01-22', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparison of Analgesic Effect: Single vs Four ISWI', 'timeFrame': '5, 30, 45, and 90 minutes after intervention', 'description': 'Change in pain intensity (VAS) at 5, 30, 45, and 90 minutes comparing participants receiving a single intradermal sterile water injection (0.5 ml) versus four injections (0.25 ml each, total 1 ml). This assesses whether multiple injections provide faster or greater pain relief than a single injection.'}], 'primaryOutcomes': [{'measure': 'Pain Reduction at 30 Minutes (VAS)', 'timeFrame': '30 minutes after intervention', 'description': 'Change in pain intensity measured using the Visual Analog Scale (VAS) from baseline (before intervention) to 30 minutes after treatment. A decrease of ≥2 points on the VAS is considered effective analgesia.'}], 'secondaryOutcomes': [{'measure': 'Pain Reduction at Other Time Points (VAS)', 'timeFrame': '5, 45, and 90 minutes after intervention', 'description': 'Proportion of participants requiring additional pain medication during the 90-minute observation period after the assigned intervention.'}, {'measure': 'Need for Rescue Analgesics', 'timeFrame': '5, 30, 45, and 90 minutes after intervention', 'description': 'Proportion of participants requiring additional pain medication during the 5, 30, 45, and 90 minutes observation period after the assigned intervention.'}, {'measure': 'Patient Satisfaction', 'timeFrame': '90 minutes after intervention', 'description': 'Patient-reported satisfaction with pain management, measured on a 5-point Likert scale at the end of observation (90 minutes).'}, {'measure': 'Adverse Events', 'timeFrame': '5, 30, 45, and 90 minutes after intervention', 'description': 'All treatment-related adverse events, including injection site pain, nausea, hypotension, or other complications, monitored at 5, 30, 45, and 90 minutes post-intervention.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renal Colic', 'Urinary Stones', 'Intradermal Sterile Water Injection', 'Intravenous Morphine', 'Pain Management'], 'conditions': ['Renal Colic', 'Urolithiasis']}, 'referencesModule': {'references': [{'pmid': '32571630', 'type': 'RESULT', 'citation': 'Golcuk Y, Demir A, Yildirim B, Acar E. Intradermal sterile water injection in acute renal colic. Am J Emerg Med. 2021 Feb;40:204. doi: 10.1016/j.ajem.2020.05.060. Epub 2020 May 25. No abstract available.'}, {'pmid': '40956348', 'type': 'RESULT', 'citation': 'Perros I, Sokhal BS, Swift C, Kitchen M, Mallen C, Somani B. Sterile water injections for analgesia in renal colic: a meta-analysis of level 1 evidence. World J Urol. 2025 Sep 16;43(1):557. doi: 10.1007/s00345-025-05920-x.'}, {'pmid': '37823931', 'type': 'RESULT', 'citation': 'Aykanat MC, Kilic M, Cimilli Ozturk T, Ustaalioglu I, Ak R. The efficacy of intradermal sterile water application in severe renal colic: a randomised clinical trial. Urolithiasis. 2023 Oct 12;51(1):121. doi: 10.1007/s00240-023-01496-6.'}, {'pmid': '32444296', 'type': 'RESULT', 'citation': 'Moussa M, Papatsoris AG, Chakra MA. Intradermal sterile water injection versus diclofenac sodium in acute renal colic pain: A randomized controlled trial. Am J Emerg Med. 2021 Jun;44:395-400. doi: 10.1016/j.ajem.2020.04.079. Epub 2020 Apr 29.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare intradermal sterile water injections (ISWI) with intravenous morphine for pain relief in adults with acute renal colic caused by urinary stones. Renal colic is a common emergency characterized by sudden, severe flank pain. Rapid and effective pain control is critical for proper diagnosis and treatment.\n\nTraditional pain management uses NSAIDs or opioids like morphine, which can cause side effects or be limited in certain patients. ISWI is a simple, low-cost, non-systemic method that may provide rapid pain relief by stimulating skin nerves, which can reduce pain signals in the spinal cord and brain.\n\nIn this randomized, controlled, double-blind trial, adult patients with confirmed renal stones and pain ≥4/10 on the visual analog scale (VAS) will be assigned to one of three groups:\n\n1. Single ISWI injection\n2. Four ISWI injections\n3. Intravenous morphine\n\nPain will be measured at 5, 30, 45, and 90 minutes after treatment. The main goal is to determine whether ISWI is not inferior to morphine in reducing pain at 30 minutes. Secondary goals include comparing the speed and intensity of pain relief between one versus four injections, the need for additional pain medication, and patient satisfaction.\n\nAll patients will be monitored for safety, and adverse effects will be recorded. The study follows strict ethical guidelines, including informed consent.\n\nIf successful, ISWI could provide a safe, effective, and easily available alternative to morphine for rapid pain relief in renal colic, with minimal side effects, and guide the best injection strategy for optimal patient comfort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Acute renal colic with pain score ≥ 4 on the Visual Analog Scale (VAS)\n* Urolithiasis confirmed by low-dose abdominopelvic CT scan\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Absence of urinary stones on imaging\n* Known allergy or contraindication to morphine or sterile water injection\n* Severe renal failure\n* Local skin infection at the injection site\n* Pregnancy or breastfeeding\n* Inability to understand the study or provide informed consent'}, 'identificationModule': {'nctId': 'NCT07378904', 'acronym': 'ISWI-Morph', 'briefTitle': 'Sterile Water Injection vs Morphine for Renal Colic', 'organization': {'class': 'OTHER', 'fullName': 'University Tunis El Manar'}, 'officialTitle': 'Intradermal Sterile Water Injection Versus Intravenous Morphine for Renal Colic: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HTHEC-2026-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Intradermal Sterile Water Injection (1 ISWI)', 'description': 'Participants receive 0.5 ml of sterile water injected intradermally at the point of maximal pain in the thoraco-lumbar region (T11-L4). Pain relief is assessed at 5, 30, 45, and 90 minutes.', 'interventionNames': ['Procedure: Single Intradermal Sterile Water Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Intradermal Sterile Water Injections (4 ISWI)', 'description': 'Participants receive 1 ml of sterile water divided into four intradermal injections of 0.25 ml each, spaced around the point of maximal pain in the thoraco-lumbar region (T11-L4). Pain relief is assessed at 5, 30, 45, and 90 minutes.', 'interventionNames': ['Procedure: Multiple Intradermal Sterile Water Injections']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous Morphine', 'description': 'Participants receive intravenous morphine at a dose of 0.1 mg/kg, administered according to local emergency protocols. Pain relief is assessed at 5, 30, 45, and 90 minutes.', 'interventionNames': ['Drug: Intravenous Morphine']}], 'interventions': [{'name': 'Single Intradermal Sterile Water Injection', 'type': 'PROCEDURE', 'description': 'single 0.5 ml sterile water injection is administered intradermally at the point of maximal pain in the thoraco-lumbar region (T11-L4). Pain will be assessed at 5, 30, 45, and 90 minutes.', 'armGroupLabels': ['Single Intradermal Sterile Water Injection (1 ISWI)']}, {'name': 'Multiple Intradermal Sterile Water Injections', 'type': 'PROCEDURE', 'description': '1 ml sterile water is divided into four intradermal injections of 0.25 ml each, spaced around the point of maximal pain in the thoraco-lumbar region (T11-L4). Pain will be assessed at 5, 30, 45, and 90 minutes.', 'armGroupLabels': ['Multiple Intradermal Sterile Water Injections (4 ISWI)']}, {'name': 'Intravenous Morphine', 'type': 'DRUG', 'description': 'Morphine is administered intravenously at 0.1 mg/kg according to local emergency protocols. Pain will be assessed at 5, 30, 45, and 90 minutes.', 'armGroupLabels': ['Intravenous Morphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1008', 'city': 'Tunis', 'state': 'Tunis Governorate', 'country': 'Tunisia', 'facility': 'Habib Thameur Teaching Hospital', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Tunis El Manar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Sami Chebbi', 'investigatorAffiliation': 'University Tunis El Manar'}}}}